Category Archives: New Jersey Stem Cells

P T. 2014 Dec; 39(12): 846-847, 854-857.

Ms. Reisman is a freelance medical writer living near Philadelphia, Pennsylvania. Ms. Adams is a Pennsylvania-based independent journalist.

Disclosure: The authors report that they have no commercial or financial relationships in regard to this article.

In September 2014, the Sanford Stem Cell Clinical Center at the University of California, San Diego (UCSD) Health System announced the launch of a groundbreaking clinical trial to assess the safety of neural stem cellbased therapy in patients with chronic spinal cord injury. Researchers hope that the transplanted stem cells will develop into new neurons that replace severed or lost nerve connections and restore at least some motor and sensory function.1

Two additional clinical trials at UCSD are testing stem cellderived therapy for type-1 diabetes and chronic lymphocytic leukemia, the most common form of blood cancer.1

These three studies are significant in that they are among the first efforts in stem cell research to make the leap from laboratory to human clinical trials. While the number of patients involved in each study is small, researchers are optimistic that as these trials progress and additional trials are launched, a greater number of patients will be enrolled. UCSD reports that trials for heart failure, amyotrophic lateral sclerosis, and blindness are in planning stages.1

The study of stem cells offers great promise for better understanding basic mechanisms of human development, as well as the hope of harnessing these cells to treat a wide range of diseases and conditions.2 However, stem cell research particularly human embryonic stem cell (hESC) research, which involves the destruction of days-old embryoshas also been a source of ongoing ethical, religious, and political controversy.2

In 1973, the Department of Health, Education, and Welfare (now the Department of Health and Human Services) placed a moratorium on federally funded research using live human embryos.3,4 In 1974, Congress adopted a similar moratorium, explicitly including in the ban embryos created through in vitro fertilization (IVF). In 1992, President George H.W. Bush vetoed legislation to lift the ban, and in 2001, President George W. Bush issued an executive order banning federal funding on stem cells created after that time.3,4 Some states, however, have permitted their limited use. New Jersey, for example, allows the harvesting of stem cells from cloned human embryos, whereas several other states prohibit the creation or destruction of any human embryos for medical research.3,4

In 2009, shortly after taking office, President Barack Obama lifted the eight-year-old ban on federally funded stem cell research, allowing scientists to begin using existing stem cell lines produced from embryos left over after IVF procedures.5 (A stem cell line is a group of identical stem cells that can be grown and multiplied indefinitely.)

The National Institutes of Health (NIH) Human Embryonic Stem Cell Registry6 lists the hESCs eligible for use in NIH-funded research. At this writing, 283 eligible lines met the NIHs strict ethical guidelines for human stem cell research pertaining to the embryo donation process.7 For instance, to get a human embryonic stem cell line approved, grant applicants must show that the embryos were donated by individuals who sought reproductive treatment and who gave voluntary written consent for the human embryos to be used for research purposes. 8 The ESCs used in research are not derived from eggs fertilized in a womans body.9

Because of the separate legislative ban, it is still not possible for researchers to create new hESC lines from viable embryos using federal funds. Federal money may, however, be used to research lines that were derived using private or state sources of funding.5

While funding restrictions and political debates may have slowed the course of stem cell research in the United States,10 the field continues to evolve. This is evidenced by the large number of studies published each year in scientific journals on a wide range of potential uses across a variety of therapeutic areas.1113

The Food and Drug Administration (FDA) has approved numerous stem cellbased treatments for clinical trials. A 2013 report from the Pharmaceutical Research and Manufacturers of America lists 69 cell therapies as having clinical trials under review with the FDA, including 15 in phase 3 trials. The therapeutic categories represented in these trials include cardiovascular disease, skin diseases, cancer and related conditions, digestive disorders, transplantation, genetic disorders, musculoskeletal disorders, and eye conditions, among others.14

Still, the earliest stem cell therapies are likely years away. To date, the only stem cellbased treatment approved by the FDA for use in this country is for bone marrow transplantation.15 As of 2010 (the latest year for which data are available), more than 17,000 blood cancer patients had had successful stem cell transplants.16

Research on stem cells began in the late 19th century in Europe. German biologist Ernst Haeckel coined the term stem cell to describe the fertilized egg that becomes an organism.17

In the U.S., the study of adult stem cells took off in the 1950s when Leroy C. Stevens, a cancer researcher based in Bar Harbor, Maine, found large tumors in the scrotums of mice that contained mixtures of differentiated and undifferentiated cells, including hair, bone, intestinal, and blood tissue. Stevens and his team concluded that the cells were pluripotent, meaning they could differentiate into any cell found in a fully grown animal. Stem cell scientists are using that carefully documented research today.17

In 1968, Robert A. Good, MD, PhD, at the University of Minnesota, performed the first successful bone marrow transplant on a child suffering from an immune deficiency. Scientists subsequently discovered how to derive ESCs from mouse embryos and in 1998 developed a method to take stem cells from a human embryo and grow them in a laboratory.17

Many degenerative and currently untreatable diseases in humans arise from the loss or malfunction of specific cell types in the body.9 While donated organs and tissues are often used to replace damaged or dysfunctional ones, the supply of donors does not meet the clinical demand.18 Stem cells seemingly provide a renewable source of replacement cells and tissues for transplantation and the potential to treat a myriad of conditions.

Stem cells have two important and unique characteristics: First, they are unspecialized and capable of renewing themselves through cell division. When a stem cell divides, each new cell has the potential either to remain a stem cell or to differentiate into other kinds of cells that form the bodys tissues and organs. Stem cells can theoretically divide without limit to replenish other cells that have been damaged.9

Second, under certain controlled conditions, stem cells can be induced to become tissue- or organ-specific cells with special functions. They can then be used to treat diseases affecting those specific organs and tissues. While bone marrow and gut stem cells divide continuously throughout life, stem cells in the pancreas and heart divide only under appropriate conditions.9

There are two main types of stem cells: 1) embryonic stem cells (ESCs), found in the embryo at very early stages of development; and 2) somatic or adult stem cells (ASCs), found in specific tissues throughout the body after development.9

The advantage of embryonic stem cells is that they are pluripotentthey can develop into any of the more than 200 cell types found in the body, providing the potential for a broad range of therapeutic applications. Adult stem cells, on the other hand, are thought to be limited to differentiating into different cell types of their tissue of origin.9 Blood cells, for instance, which come from adult stem cells in the bone marrow, can specialize into red blood cells, but they will not become other cells, such as neurons or liver cells.

A significant advantage of adult stem cells is that they offer the potential for autologous stem cell donation. In autologous transplants, recipients receive their own stem cells, reducing the risk of immune rejection and complications. Additionally, ASCs are relatively free of the ethical issues associated with embryonic stem cells and have become widely used in research.

Representing a relatively new area of research, induced pluripotent stem cells (iPSCs) are adult stem cells that have been genetically reprogrammed back to an embryonic stem celllike state. The reprogrammed cells function similarly to ESCs, with the ability to differentiate into any cell of the body and to create an unlimited source of cells. So iPSCs have significant implications for disease research and drug development.

Pioneered by Japanese researchers in 2006, iPSC technology involves forcing an adult cell, such as a skin, liver, or stomach cell, to express proteins that are essential to the embryonic stem cell identity. The iPSC technology not only bypasses the need for human embryos, avoiding ethical objections, but also allows for the generation of pluripotent cells that are genetically identical to the patients. Like adult cells, these unlimited supplies of autologous cells could be used to generate transplants without the risk of immune rejection.9

In 2013, researchers at the Spanish National Cancer Research Centre in Madrid successfully reprogrammed adult cells in mice, creating stem cells that can grow into any tissue in the body. Prior to this study, iPSCs had never been grown outside Petri dishes in laboratories.19 And, in July 2013, Japans health minister approved the first use of iPSCs in human trials. The Riken Center for Developmental Biology will use the cells to attempt to treat age-related macular degeneration, a common cause of blindness in older people. The small-scale pilot study would test the safety of iPSCs transplanted into patients eyes.20

According to David Owens, PhD, Program Director of the Neuroscience Center at NIHs National Institute of Neurological Disorders and Stroke (NINDS), one of the fundamental hurdles to using stem cells to treat disease is that scientists do not yet fully understand the diseases themselves, that is, the genetic and molecular signals that direct the abnormal cell division and differentiation that cause a particular condition. You want that before you propose a therapeutic, he says, because you want a firm, rational basis for what youre trying to do, what youre trying to change.

Although most of the media attention around stem cells has focused on regenerative medicine and cell therapy, researchers are finding that iPSCs, in particular, hold significant promise as tools for disease modeling.21,22 A major barrier to research is often inaccessibility of diseased tissue for study.23 Because iPSCs can be derived directly from patients with a given disease, they display all of the molecular characteristics associated with the disease, thereby serving as useful models for the study of pathological mechanisms.

The biggest payoff early on will be using these cells as a tool to understand the disease better, says Dr. Owens. For instance, he explains that creating dopamine neurons from iPSC lines could help scientists more closely study the mechanisms behind Parkinsons disease. If we get a better handle on the disorders themselves, then that will also help us generate new therapeutic targets. Recent studies show the use of these patient-specific cells to model other neurodegenerative disorders, including Alzheimers and Huntingtons diseases.2426

In addition to using iPSC technology, it is also possible to derive patient-specific stem cell lines using an approach called somatic cell nuclear transfer (SCNT). This process involves adding the nuclei of adult skin cells to unfertilized donor oocytes. As reported in spring 2014, a team of scientists from the New York Stem Cell Foundation Research Institute and Columbia University Medical Center used SCNT to create the first disease-specific embryonic stem cell line from a patient with type-1 diabetes. The insulin-producing cells have two sets of chromosomes (the normal number in humans) and could potentially be used to develop personalized cell therapies.27

The development of iPSCs and related technologies may help address the ethical concerns and open up new possibilities for studying and treating disease, but there are still barriers to overcome. One major obstacle is the tendency of iPSCs to form tumors in vivo. Using viruses to genomically alter the cells can trigger the expression of cancer-causing genes, or oncogenes.28

Much more research is needed to understand the full nature and potential of stem cells as future medical therapies. It is not known, for example, how many kinds of adult stem cells exist or how they evolve and are maintained.9

Some of the challenges are technical, Dr. Owens explains. For instance, generating large enough numbers of a cell type to provide the amounts needed for treatment is difficult. Some adult stem cells have a very limited ability to divide, making it difficult to multiply them in large numbers. Embryonic stem cells grow more quickly and easily in the laboratory. This is an important distinction because stem cell replacement therapies require large numbers of cells.29

Also, says Dr. Owens, stem cell transplants present immunological hurdles: If you do introduce cells into a tissue, will they be rejected if theyre not autologous cells? Or, you might have immunosuppression with the individual who received the cells, and then there are additional complications involved with that. Thats still not entirely clear.

Such safety issues need to be addressed before any new stem cellbased therapy can advance to clinical trials with real patients. According to Dr. Owens, the preclinical testing stage typically takes about five years. This would include assessment of toxicity, tumorigenicity, and immunogenicity of the cells in treating animal models for disease.30

Those are things we have to continually learn about and try to address. It will take time to understand them better, Dr. Owens says. Asked about the importance of collaboration in overcoming the scientific, regulatory, and financial challenges that lie ahead, he says, Its unlikely that one entity could do it all alone. Collaboration is essential.

Ultimately, stem cells have huge therapeutic potential, and numerous studies are in progress at academic institutions and biotechnology companies around the country. Studies at the NIH span multiple disciplines, notes Dr. Owens, who oversees funding for stem cell research at NINDS. ( shows the recent history of NIH funding for stem cell research.) He describes one area of considerable interest as the promotion of regeneration in the brain based on endogenous stem cells. Until recently, it was believed that adult brain cells could not be replaced. However, the discovery of neurogenesis in bird brains in the 1980s led to startling evidence of neural stem cells in the human brain, raising new possibilities for treating neurodegenerative disorders and spinal cord injuries.31

Its a fascinating idea, says Dr. Owens. Its unclear still what the functions of those cells are. They could probably play different roles in different species, but just the fundamental properties themselves are very interesting. He cites a number of NINDS-funded studies looking at those basic properties.

In another NIH-funded study, Advanced Cell Technology (ACT), a Massachusetts-based biotechnology company, is testing the safety of hESC-derived retinal cells to treat patients with an eye disease called Stargardts macular dystrophy. A second ACT trial is testing the safety of hESC-derived retinal cells to treat age-related macular degeneration patients.32,33

In April 2014, scientists at the University of Washington reported that they had successfully regenerated damaged heart muscles in monkeys using heart cells created from hESCs. The research, published in the journal Nature, was the first to show that hESCs can fully integrate into normal heart tissue.34

The study did not answer every question and had its complicationsit failed to show whether the transplanted cells improved the function of the monkeys hearts, and some of the monkeys developed arrhythmias.34,35 Still, the researchers are optimistic that it will pave the way for a human trial before the end of the decade and lead to significant advances in treating heart disease.29

In May 2014, Asterias Biotherapeutics, a California-based biotechnology company focused on regenerative medicine, announced the results of a phase 1 clinical trial assessing the safety of its product AST-OPC1 in patients with spinal cord injuries.36 The study represents the first-in-human trial of a cell therapy derived from hESCs. Results show that all five subjects have had no serious adverse events associated with the administration of the cells, with the AST-OPC1 itself, or with the immunosuppressive regimen. A phase 1/2a dose-escalation study of AST-OPC1 in patients with spinal cord injuries is awaiting approval from the FDA.37

The FDA itself has a team of scientists studying the potential of mesenchymal stem cells (MSCs), adult stem cells traditionally found in the bone marrow. Multipotent stem cells, MSCs differentiate to form cartilage, bone, and fat and could be used to repair, replace, restore, or regenerate cells, including those needed for heart and bone repair.38

Publicly available information about federally and privately funded clinical research studies involving stem cells can be found at http://clinicaltrials.gov. However, the FDA cautions that the information provided on that site is supplied by the product sponsors and is not reviewed or confirmed by the agency.

The biggest payoff early on will be using these cells as a tool to understand the disease better. If we get a better handle on the disorders themselves, then that will also help us generate new therapeutic targets.

David Owens, PhD, Program Director, Neuroscience Center, National Institute of Neurological Disorders and Stroke

Stem cell research policy varies significantly throughout the world as countries grapple with the scientific and social implications. In the European Union, for instance, stem cell research using the human embryo is permitted in Belgium, Britain, Denmark, Finland, Greece, the Netherlands, and Sweden; however, it is illegal in Austria, Germany, Ireland, Italy, and Portugal.39

In those countries where cell lines are accessible, research continues to create an array of scientific advances and widen the scope of stem cell application in human diseases, disorders, and injuries. For example, in February 2014, Cellular Biomedicine Group, a China-based company, released the six-month follow-up data analysis of its phase 1/2a clinical trial for ReJoin, a human adipose-derived mesenchymal precursor cell (haMPC) therapy for knee osteoarthritis. The study, which tested the safety and efficacy of intra-articular injections of autologous haMPCs to reduce inflammation and repair damaged joint cartilage, showed knee pain was significantly reduced and knee mobility was improved.40 And the journal Stem Cell Research & Therapy reported that researchers at the University of Adelaide in Australia recently completed a project showing stem cells taken from teeth could form complex networks of brain-like cells. Although the cells did not grow into full neurons, the researchers say that it will happen given time and the right conditions.41

In February 2014, the U.S. Court of Appeals for the District of Columbia Circuit upheld a 2012 ruling that a patients stem cells for therapeutic use fall under the aegis of the FDA.42 The appeals case involved the company Regenerative Sciences, which was using patients MSCs in its Regenexx procedure to treat orthopedic problems.43

The FDAs Center for Biologics Evaluation and Research (CBER) regulates human cells, tissues, and cellular and tissue-based products (HCT/P) intended for implantation, transplantation, infusion, or transfer into a human recipient, including hematopoietic stem cells. Under the authority of Section 361 of the Public Health Service Act, the FDA has established regulations for all HCT/Ps to prevent the transmission of communicable diseases.44

The Regenexx case highlights an ongoing debate about whether autologous MSCs are biological drugs subject to FDA approval or simply human cellular and tissue products. Some medical centers collect, concentrate, and reinject MSCs into a patient to treat osteoarthritis but do not add other agents to the injection. The FDA contends that any process that includes culturing, expansion, and added growth factors or antibiotics requires regulation because the process constitutes significant manipulation. Regenerexx has countered that the process does not involve the development of a new drug, which could be given to a number of patients, but rather a patients own MSCs, which affects just that one patient.

Ensuring the safety and efficacy of stem cellbased products is a major challenge, says the FDA. Cells manufactured in large quantities outside their natural environment in the human body can potentially become ineffective or dangerous and produce significant adverse effects such as tumors, severe immune reactions, or growth of unwanted tissue. Even stem cells isolated from a persons own tissue can potentially present these risks when put into an area of the body where they could not perform the same biological function that they were originally performing. Stem cells are immensely complex, the FDA cautionsfar more so than many other FDA-regulated productsand they bring with them unique considerations for meeting regulatory standards.

To date, no U.S. companies have received FDA approval for any autologous MSC therapy, although a study is ongoing to assess the feasibility and safety of autologous MSCs for osteoarthritis.45 One of the major risks with MSCs is that they could potentially lead to cancer or differentiation into bone or cartilage.46

The numerous stem cell studies in progress across the globe are only a first step on the long road toward eventual therapies for degenerative and life-ending diseases. Because of their unlimited ability to self-renew and to differentiate, embryonic stem cells remain, theoretically, a potential source for regenerative medicine and tissue replacement after injury or disease. However, the difficulty of producing large quantities of stem cells and their tendency to form tumors when transplanted are just a few of the formidable hurdles that researchers still face. In the meantime, the shorter-term payoff of using these cells as a tool to better understand diseases has significant implications.

Social and ethical issues around the use of embryonic stem cells must also be addressed. Many nations, including the U.S., have government-imposed restrictions on either embryonic stem cell research or the production of new embryonic stem cell lines. Induced pluripotent stem cells offer new opportunities for development of cell-based therapies while also providing a way around the ethical dilemma of using embryos, but just how good an alternative they are to embryonic cells remains to be seen.

It is clear that many challenges must be overcome before stem cells can be safely, effectively, and routinely used in the clinical setting. However, their potential benefits are numerous and hold tremendous promise for an array of new therapies and treatments.

The authors wish to thank the FDA staff for their support in writing this article and Rachael Conklin, Consumer Safety Officer, Consumer Affairs Branch, Division of Communication and Consumer Affairs, Center for Biologics Evaluation and Research, for her help in organizing the comments provided by FDA staff.

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Stem Cell Therapy: a Look at Current Research, Regulations ...

Advance Market Analytics published a new research publication on Stem Cells Market Insights, to 2026 with 232 pages and enriched with self-explained Tables and charts in presentable format. In the Study you will find new evolving Trends, Drivers, Restraints, Opportunities generated by targeting market associated stakeholders. The growth of the Stem Cells Market was mainly driven by the increasing R&D spending across the world.

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Smith & Nephew (United Kingdom),Celgene Corporation (United States),BIOTIME, INC. (United States),Cynata (Australia),Applied Cell Technology (Hungary),STEMCELL Technologies Inc. (Canada),BioTime Inc. (United States),Cytori Therapeutics, Inc. (United States),Astellas Pharma Inc. (Japan),U.S. Stem Cell, Inc. (United States),Takara Holdings. (Japan)

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Scope of the Report of Stem Cells

The stem cell is used for treating chronic diseases such as cardiovascular disorders, cancer, diabetes, and others. Growing research and development in stem cell isolation techniques propelling market growth. For instance, a surgeon from Turkey developed a method for obtaining stem cells from the human body without enzymes which are generally used for the isolation of stem cells. Further, growing healthcare infrastructure in the developing economies and government spending on the life science research and development expected to drive the demand for stem cell market over the forecasted period.

Market Trend:

Emphasizing On Development of Regenerative Medicine

Technological Advancement in Stem Cell Harvesting and Isolation Techniques

Market Drivers:

Rising Prevalence of Chronic Diseases such as Cardiovascular Disorders, Cancer, and others

Growing Healthcare Infrastructure in the Developing Economies

Challenges:

Lack of Awareness Regarding Stem Cell Therapy in the Low and Middle Income Group Countries

Opportunities:

Growing Demand for Cellular Therapies

Rising Application of Autologous Therapy

The titled segments and sub-section of the market are illuminated below:by Type (Adult Stem Cells (Neuronal, Hematopoietic, Mesenchymal, Umbilical Cord, Others), Human Embryonic Stem Cells (hESC), Induced Pluripotent Stem Cells, Very Small Embryonic-Like Stem Cells), Application (Regenerative Medicine (Neurology, Orthopedics, Oncology, Hematology, Cardiovascular and Myocardial Infraction, Injuries, Diabetes, Liver Disorder, Incontinence, Others), Drug Discovery and Development), Technology (Cell Acquisition (Bone Marrow Harvest, Umbilical Blood Cord, Apheresis), Cell Production (Therapeutic Cloning, In-vitro Fertilization, Cell Culture, Isolation), Cryopreservation, Expansion and Sub-Culture), Therapy (Autologous, Allogeneic)

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Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.

Strategic Points Covered in Table of Content of Global Stem Cells Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Stem Cells market

Chapter 2: Exclusive Summary the basic information of the Stem Cells Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Stem Cells

Chapter 4: Presenting the Stem Cells Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying market size by Type, End User and Region 2015-2020

Chapter 6: Evaluating the leading manufacturers of the Stem Cells market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries (2021-2026).

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Stem Cells Market is a valuable source of guidance for individuals and companies in decision framework.

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Stem Cells Market to Witness Gigantic Growth by 2026 LSMedia - LSMedia

Learn Northeast and South Jersey Coalition activist denounce Governor Murphys attempt to increase Abortions just before birth.

This Saturday @ 10:00 AM Prolife Activist of the region will rally at 10:00AM @ Cherry Hill Womens Center 502 Kings Highway North, Cherry Hill New Jersey.

New Jerseys Governor Murphy along with prominent Democrat leadership across the nation have sought to push late term abortion legislation that many are calling radical and unconscionable.Christine Flaherty of LifeNet stated, The Reproductive Freedom Act totally is contrary to the will of the people. The Governor again is bypassing the will of the citizens he is to represent. This legislation is clearly an attempt to increase what the people do not want which is abortions just before birth. Despicable!

According to the most recent Marist Poll (Jan 2021) 7-10 Americans, including nearly half who identify as pro-choice, want significant restrictions on abortion. Moreover, 58% of all Americans oppose using tax dollars for abortion, 55%want to ban abortions after 20 weeks, 70% of Americans oppose abortion if a child is born with Downs Syndrome, 80% of Americans believe that laws can protect both a pregnant woman and the life of her unborn child.

Gwen Swartznader of The South Jersey Coalition commented, this bill would profoundly ignore the will of the people, even those who are pro-choice. This facility will produce the late term abortions Governor Murphy wants. Im appalled.

Rev Childress of Learnnortheast said, Once again without caucus or consent of the people. Thats how Roe Vs Wade was given to the people as well as this attempt for the Reproductive Freedom Act. These eugenic laws are produced to victimize the African American community habitually. We have asked New Jersey as well as America to stop funding racism. The skeptics now know what we have been saying for years! The African American community and people of color are targeted by the abortion Industry!Dr. Childress is referring to the recent revelations discovered at the University of Pittsburg which revealed racial targeting for the harvesting of human fetal parts. A written proposal retrieved by Judicial Watch stated, of its planned aborted subjects Pitt desired 50% to be minority fetuses. The proposal suggests that the subjects be diverse because Pittsburgh is diverse. The U.S. Census Bureau shows the city of Pittsburgh is close to 70% white. The university would harvest 50% of aborted babies from white mothers and 50% from minority mothers with 25% of the babies specifically coming from black mothers. Blacks make up 12.4 of the population but make up 36% of the abortions nationally.

Ethel Hermanue of LifeNet South Jersey stated , I know Cherry Hill Womens Center serves many women coming in from Philadelphia. This center no doubt will be accommodating the needs of the University of Pittsburg for minority babies. The Reproductive Freedom Act will help them do that.Retired surgeon Kathleen Ruddy and author of the recently released book, The Viability of Roe, makes an eye-opening discovery about the lucrativeness of harvesting fetal tissue which she points out in her book. I found a newspaper article in which the reporter stated that a small vile of fetal liver stem cells cost about $24,000, who buys and sells and uses fetal tissue acquired from abortion clinics Denise Grady and Nicholas St. Fleur, The New York Times July 27, 2015. Think about it, one tiny vile of fetal liver stem cells went for $24,000 a few years ago. What would two kidneys, a spleen, pancreas, and small intestine, where important blood cells of the immune system are made, the bone marrow, two testes, two ovaries, the eyes, the inner ears, the spinal cord, or the brain go for?

The Slave Block is still alive and well in the United States, Rev Childress Stated, Body Parts for Sale from those who have been declared non-citizens, and they call me radical. This undercover sting revealed body parts being removed even before the death of the child, The Third Reich didnt do such abominations!

For further information go to SaySoMarch.com or dial 1-866-242-4997

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Peaceful Protest at Cherry Hill Women's Center Warning Public of Increase in Late Term Abortions In New Jersey. - InsiderNJ

Sushi-loving diners in Callie will soon be partaking of test-tube salmon, compliments of San Francisco-based firm Wildtype. The company touts itself as Building a better food system by pioneering cellular agriculture to grow delicious cuts of our favorite seafood no fishing or fish farming required. I know, just when you think life cant get any weirder.

The companys website hypes its cutting-edge efforts as reinventing seafood, with a clever emphasis on inventing, since the entire process has come about through lab experimentation on handpicked cells of salmon, in the vein of stem cell exploration.

The seeds of Wildtypes chunks seed money has already been gotten aplenty comes via the choicest cells of the finest wild salmon, including king salmon, the finest and fattiest known. Once cells have been adroitly procured, the cellular growing process is on, as the meat of the matter is grown upon a type of organic plant-based scaffolding until done or ripe or something.

The plant-based scaffolding we provide for the cells to grow on, along with all the necessary nutrients like sugars, amino acids, and fats we deliver in solution, allows for the formation of the complex textures that were able to create for all types of sushi products spanning sashimi, nigiri and maki rolls, explains the companys cofounder Ary Elfenbein, a cardiologist and molecular biologist.

Wildtypes test-tube salmon is rather frighteningly identical to the real swimming thing, with a fat composition like the donor fish, including levels of healthy omega-3 fatty acids, but none of the heavy metals, microplastics, parasites, or antibiotics found in most salmon, per the companys website.

One of this methods claims to fame is how it might reduce the need for environmentally suspect fish farming.

Net pens used in fish farming pollute sensitive coastal waterways with concentrated excrement. Many farms have had escape events, introducing invasive species into sensitive ecosystems that compete with local fish populations, company cofounder Justin Kolbeck recently told Forbes magazine.

It should be emphasized this grown-in-house fish product is not even remotely related to soy-based imitation seafood and meats. The end products DNA makeup is salmon all the way; theres simply no energy wasted on the little things, like growing skeletons, scales, internal organs or brains.

Anyone remember the sci-fi thriller The Blob? Just asking for no particular reason.

To buttress Kolbecks point about escape, its profoundly unlikely that a chunk of Wildtype salmon will ooze out of the lab, leaving behind a telltale slime trail along the escape route before seeping seaward to freedom. Of course, should that happen, it would be quite a hook-up sight for any angler reeling in a big chunk of raw salmon meat. Anyone know how to clean this thing? Oh, wait, now that I think about it

OK, should we buy into this New Age salmon meat when it hits close to home? It will hit select market by next month or so, after which the company hopes to eventually produce tons and tons of its highly salmonesque stuff. Also, reports indicate other companies are champing at the test tube to get in on cellular seafood.

Personally, I somewhat prefer my seafood has seen the sea. That said, there is no doubt lab-grown seafood could be a healthy alternative to our overfishing of the worlds oceans. I can even foresee both wild-caught salmon and the beaker-based variety being served at a meal and folks clearly preferring the Wildtype offering, calling the natural too gamey.

As to the early taste tests of freshly picked/harvested Wildtype salmon, even educated buds are giving it flying colors speaking of which, the color of Wildtype salmon is identical to the donor fishs flesh color since it is the exact same fish again with the DNA thing.

For you travelers, if youre out San Fran way, the Wildtype company is all but begging folks to stop on in.

Wildtype wants to establish a high standard of education, trust, and transparency with our customers and the public. We want to show people where their food comes from and how its made, offer the owners.

Ill wax snarky by wondering if it might not be best to place test-tube salmon making in the same realm as, say, scrapple making. Philly folks get my dont ask/dont tell drift.

By the by, there have been some unique growing pains to developing a better bodiless salmon. For some unknown cell binding reason, the first chunks did not take at all well to cooking. The meat broke into what might be called individual component parts hundreds of tiny undefinable pieces of salmon essence. I cant imagine what that would have looked like and I would surely have been the only one in the lab laughing my ass off.

The last I heard, the creative minds of the company are tweaking the growing process so we can someday buy San Fran salmon for more than just sashimi, sushi and sausages.

I will absolutely be among the early-on buyers of salmon a la lab. One problem I see is naming the stuff with full disclosure in tow. There must be a distinct, immediately recognizable terminology. Ill be the first to admit that test-tube salmon would be off-putting. Less so would be manmade salmon or sea-free salmon. The company itself might run with cellular salmon, based on its self-hype that Wildtype is pioneering cellular agriculture to grow delicious cuts of our favorite seafood no fishing or fish farming required.

ECO-UGLY ABANDONMENT: I need to combine two tales in one since both have to do with mankind unloosing nonindigenous species into our delicate Pinelands environment.

The more recent of the two comes via a jungle-ish find by Division of Fish and Wildlife conservation officers. While on patrol, the officers came across your everyday boa constrictor crossing a dirt road. Yes, its everyday if you live in frickin Central America!

The 4-footer was found in a state Wildlife Management Area. Id safely venture to say it was not simply taking in the sights of our outback before making the long slither back to some tropical rainforest.

Forgoing the other minuscule possibility that the boas owner had simply been out walking it only to have his minion slip its leash, this was an all too familiar case of someone ignobly abandoning a faithful critter even after it had dedicated its entire life to being a family-member pet.

OK, that might sound a bit overemotional, but such dump-offs are a lousy trick by incompetent-as-s*** pet owners.

As to what would have become of the tropical snake had it not come back to the road looking for its human buddy, I believe it was Jack London who morbidly suggested that freezing to death isnt the worst way to go. Winter would have ended the snakes unwanted flirtation with untamed freedom.

There was no chance the lone boa could have led to the Pinelands becoming a covey of constrictors even if the captured boa wore a boa, meaning it was a female.

That tale roundaboutly leads to a twinish tale of the time piranhas swam about in Stafford Forge Lake.

It was July 2007 when I got word of weird fish being caught in the historic lake, former home to a forge and cranberry bogs. As I wrote back then, A number of piranhas were recently taken by an angler using Bass Stoppers, a favorite freshwater rig. And these werent minor models of this highly nonindigenous species. One piranha was way hefty.

I recall my well-founded disbelief upon seeing the first photo of the landing. At mere first glance, I knew this hookup was a member of a world-renowned fish family that includes piranha, pacu and oscars. To me, it was clearly a piranha.

So, what in bloody hell was such a species doing in the tannin-laced, temperate zone waters of the Forge?

The answer was all too obvious: Some numbnut had released it after it had outgrown its aquarium and its welcome. Such dumpings, while displaying a touch of compassion when compared to a toilet flush-down, are quite common. In fact, many state waters are now plagued by introduced carp, the leave-behinds from anglers using cheap so-called feeder goldfish to live-line for largemouth bass and pickerel.

The sacrificial goldfish, small carp in essence, either get off the hook or are poured into lakes at the end of a fishing session. They grow rapidly into immense vegetation bottom feeders. Once established, they create such a bottom stir that it can muck up the water, impacting gamefish, which feed by sight. They also inadvertently mosey over bass and sunfish nests hollows in the sand inadvertently sucking up eggs and newborns.

As to the Forge piranhas, the hookups led to an utterly surprising finding that they had surely been there more than just one season. The hardy little devils were showing signs of prospering, likely going into a torpor state when the lake froze in winter. Fears arose as to what they were thriving upon, assuredly indigenous species.

The realization that piranhas were making themselves at home in a New Jersey lake led to fear regarding the many people and pets commonly wading right where the fish were caught. Such frets were a bit unfounded. While packs of piranhas can go gruesomely gonzo over the smell of blood and raw flesh, Ive seen naked native children in Brazil freely swim among them, with nary a single natural bris being reported. Nonetheless, N.J. Fish and Wildlife folks went on one weird-ass search-and-destroy mission by electrocuting the lake. The method shocked the hell out of the lakes inhabitants, causing them to rise woozily to the surface, where any species non grata could be removed and apologies offered to acceptable lake occupants, which quickly recovered from the buzz, all wondering What the hell was that all about?!

RUNDOWN: Weirdly, the blowfish are back in town, mainly the far west side of Barnegat Bay where they had been, then left, only to be replaced by a ton of all new puffers moving in from waters to our north. It is once again possible to best a hundred or more per chumming session.

There are also small weaks and kingfish entering the chum slick.

Weirdest chum-related hookup was a massive black drum estimated by Paul P. at 50 pounds. It was almost landed, net hovering above, before the tiny hook gave way. That is pretty far north for Barnegat Bay black drum.

Speaking of drum, its about time for red drum to make beachline passes. The state record remains at 55 pounds, a fish taken in Great Bay by Daniel Yanino in 1985.

This is an amazing time of year to chum with grass shrimp in places like Myers Hole and surely some deeper waters toward Little Egg Inlet. Such panfishing often offers as great a variety of fish species as youll ever hook during one Jersey sitting.

Considering most of the fish drawn to a shrimp chum will be juveniles, you must use circle hooks and unhook undersized fish as quickly and gently as possible. Best bet is to not even bring them aboard. A nice series of photos can be taken without fish having to pass over the gunnel.

Surfside fluking is fair. Its best when waters are at least a bit roiled. Calm, crystal-clear water periods seem to knock down the flattie action. Every now and again there is a sudsy doormat taken.

Stingrays have glided a bit north, though a few are still quite obvious along the clear-water shoreline. Ive gotten two emails regarding ways to cook ray wings. Ill give them a try. If my taste buds salute, Ill pass them on.

Triggerfish are making their typical late-summer presence known. Some nice-sized ones mixed in, way larger than they usually show down south, re-begging the question of whether these fish go back to the Deep South or move off shore for the winter. The average sheepshead size up here dwarfs the typical sheepsheads in places like the Indian and Banana rivers in Florida.

Please do not try to fillet triggers. Too much meat is utterly wasted. After gutting, simply cook them whole. Once done and they bake very quickly with skin still on pull off the now easily removed skin and dine on the delicate white meat within. Of note, there are some filefish being labeled triggerfish. They are different to a degree, but are surprisingly similar in taste.

jaymann@thesandpaper.net

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Time to Go Sushi With Cellular Salmon; When Pet Owners Tire of Their Minions - The SandPaper

Avalon GloboCare FLASH-CAR technology, will be used as an innovative messenger ribonucleic acid based technology platform that will allow researchers to create CAR cellular therapies faster than before

The collaboration will develop new cancer immunotherapy approaches and streamline manufacturing processes to bring powerful treatments to cancer patients within days instead of weeks

(), UPMC Hillman Cancer Center, and the University of Pittsburgh said they have forged a collaboration to develop new cancer immunotherapy approaches and streamline manufacturing processes to bring powerful treatments to cancer patients within days instead of weeks.

Cancer immunotherapy, which stimulates and trains a patients own immune system to target and kill tumors while leaving healthy cells intact, is an effective treatment for many cancer patients. One of these therapies, cancer immunotherapy called CAR-T, short for chimeric antigen receptor therapy, alters a patients own T-cells to kill their cancer cells.

This approach has been successful for some patients with leukemias, lymphomas and more recently, multiple myeloma, but only a limited number of patients have been able to benefit from these therapies, noted the new partners in ajoint statement.

READ:Avalon GloboCare says its planned acquisition target SenlangBio starts first-in-human clinical trial for recurrent brain cancer

The collaboration, led by Yen-Michael S Hsu, director of the Immunologic Monitoring and Cellular Products Laboratory (IMCPL) at UPMC Hillman, seeks to develop next-generation CAR-based cellular therapies to make them accessible to a wider range of cancer patients.

CAR T-cell therapies approved by the US Food and Drug Administration (FDA) are personalized therapies, made from the patients own cells. Current therapies use a DNA-based viral vector to engineer expression of the CAR against an antigen present on tumor cells. Patient cells are modified in the lab and infused back into the patient in a process that takes several weeks.

With Avalon GloboCare FLASH-CAR technology, we will use an innovative messenger ribonucleic acid (mRNA)-based technology platform that will allow researchers to create CAR cellular therapies faster than before in just one to two days, said Hsu.

We also believe this approach will reduce toxicity and overall cost associated with current CAR T-cell therapies, meaning more cancer patients could be eligible for this type of cellular therapy, he added.

The researchers are also using the technology to develop next-generation, personalized CAR T-cell therapies, including engineering cells that target more than one tumor antigen, enhancing their ability to target and kill cancer cells. Hillmans IMCPL and Avalon GloboCare are developing a treatment for patients with relapsed or refractory B-cell lymphoblastic leukemia and non-Hodgkin lymphoma.

Human clinical trials are poised to begin in mid-2022, the partners said.

Another goal, according to Hsu, is to make universal or off-the-shelf CAR-based cancer immunotherapies. Unlike personalized treatments, this universal cellular therapy will be derived from a healthy donor, manufactured in bulk and available to treat patients without delay.

A clinician could order this cellular immunotherapy in the same way as antibody or oral cancer treatment, reducing the time a patient has to wait for treatment, said Hu. Because this cellular therapy would be made in a large batch, the cost of manufacturing would be much lower, resulting in a lower cost of the final cellular therapy products for patients.

The researchers are also working to streamline and enhance the quality of CAR T-cell manufacturing with Avalons Point-of-Care modular Autonomous Processing System ((PMAPsys) onsite at UPMC Hillman, a National Cancer Institute (NCI) designated comprehensive cancer center.

Hillmans IMCPL supports investigator-initiated research and technical expertise in translating lab research into clinical biologic products.

Freehold, New Jersey-based Avalon GloboCare is a clinical stage developer of cell-based and exosome technologies and manages stem-cell banks and clinical labs.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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Avalon GloboCare, UPMC Hillman and University of Pittsburgh to develop new cancer immunotherapy - Proactive Investors USA & Canada

Newswise HACKENSACK, N.J. (DATE TK) A new study has found that using CAR T-cell therapy as the second line of treatment for diffusing large B-cell lymphoma (DLBCL) that has returned or continued to grow after initial treatment was more effective than the standard second-line regimen of care for improving event-free survival (EFS / defined as disease progression, needing to start a new lymphoma treatment, or death from any cause). Investigators from Hackensack Meridian/Hackensack University Medical Centers John Theurer Cancer Center (JTCC), a part of Georgetown Lombardi Comprehensive Cancer Center, participated in the multicenter international study, called ZUMA-7.

With a median follow-up of two years, the study showed that patients with DLBCL who received a one-time infusion of axicabtagene ciloleucel (Yescarta) experienced a 60% improvement in EFS compared with patients who received standard care with chemotherapy and autologous stem cell transplantation. Patients in the CAR T-cell therapy group also experienced a better overall response rate. The study is continuing with additional follow-up to assess the effect of the treatments on overall survival and other key endpoints.

Axicabtagene ciloleucel is currently approved by the U.S. Food and Drug Administration for the treatment of large B-cell lymphoma that relapses after or fails to respond to at least two prior regimens of therapy.

"This is a very exciting paradigm shift for the treatment of large B-cell lymphoma," explained hematologist-oncologist Lori Leslie, M.D., who led JTCC's participation in the ZUMA-7 study. "A 60% improvement in event-free survival is more dramatic than one would anticipate and suggests that early relapsers and some patients at high risk of relapse after initial treatment may benefit from proceeding directly to CAR T-cell therapy."

About 40% of patients with DLBCL will need a second regimen of treatment.

CAR T-cell therapy is a form of treatment which involves removing white blood cells called T cells from the patient, modifying them in the laboratory to train them to see a protein (called CD19) on lymphoma cells, and then multiplying them to much larger numbers. When given back to the patient intravenously, they expand further, ideally identifying and killing cancer cells anywhere in the body.CAR T-cell therapy is a form of immunotherapy and has been called a "living therapy" because the newly trained T cells continue to find and destroy cancer cells in the body.

As a leader in CAR T therapy, we are proud to be a part of this new development in research that will continue to reshape the landscape of relapsed/refractory aggressive lymphoma who fail standard regimens of chemoimmunotherapy, said Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center.

The ZUMA-7 study began in 2017 and includes 359 patients with DLBCL at 77 medical centers around the world, 30% of whom were 65 years or older. Side effects observed in the study were consistent with or even more favorable than the safety profile previously established for axicabtagene ciloleucel. The use of CAR T-cell therapy as second-line treatment did not result in any new safety concerns. Yescarta has been instrumental in transforming outcomes for DLBCL patients in third line setting. It is likely the paradigm will continue to shift towards earlier timing in patients with early failures.

"The contributions that the John Theurer Cancer Center made toward identifying a better therapy for the research and treatment of lymphoma further establishes its position as a leading center, " said Ihor Sawczuk, MD, FACS, president, Northern Region, and chief research officer, Hackensack Meridian Health. "Hackensack Meridian Health is proud to have been involved in this pivotal study."

"We are dedicated to continuing to provide the latest research-based treatments to the members of our communities," added Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack MeridianHealth. "John Theurer Cancer Center was the first center in New Jersey to be certified to offer CAR T-cell therapy and was active in research assessing its use long before its first FDA approval. We are very excited to see these promising results, which show how this powerful immunotherapy may benefit more people."

ABOUT JOHN THEURER CANCER CENTER HACKENSACK UNIVERSITY MEDICAL CENTER

John Theurer Cancer Center at Hackensack University Medical Center is New Jersey's best cancer center, as recognized by U.S. News & World Report. As a premier cancer center in the State we are also the largest and most comprehensive center dedicated to diagnosis, treatment, management, research, screening, and preventive care as well as survivorship of patients with all types of cancers. The 16 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is part of the Georgetown Lombardi Comprehensive Cancer Center, an NCI designated comprehensive cancer center. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. For additional information, please visit http://www.jtcancercenter.org

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John Theurer Cancer Center Investigators Participated in ZUMA-7 Study Showing Value of CAR T-Cell Therapy as Second-Line Treatment for Relapsed Large...

Medical professionals report dramatic and consistent success in treating patients gravely ill with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS)

AUSTIN, Texas, July 20, 2021 /PRNewswire/ -- As intensive care units across the country fill to capacity, hospital beds are in dangerously short supply, and deaths from COVID-19 continue to spike, doctors from medical centers coast to coast are reporting on the remarkable healing properties of ExoFlo, an innovative life-saving therapy that leverages the anti-inflammatory and regenerative effects of bone-marrow derived mesenchymal stem cells, when used on their most seriously ill COVID-19 patients. The physicians note that utilizing ExoFlo, administered as a single IV infusion, is safe and efficacious and is saving lives on a consistent basis.

One of the product's earliest advocates, Dr. Vik Sengupta of New York, credits ExoFlo with saving his own life. He has since used it on many critically ill patients, eagerly shared it with colleagues, and coauthored, with his wife, Dr. Sascha Sengupta, a clinical safety trial conducted at Christ Hospital in Jersey City, N.J. as part of the therapy's FDA approval process. The safety data from this study has since set the stage for the FDA approval of ExoFlo for an Investigational New Drug (IND) application for COVID-19.

"The most common cause of death among critically ill COVID-19 patients is acute respiratory distress symptom, or ARDS, in which the lungs are badly damaged, scarred and fill with fluid," explained Dr. Sengupta. "This is essentially a result of the body reacting to a threat by overproducing cytokines and other mediators of inflammation that cause damage to the lungs and other tissues in the body in a phenomenon commonly known as the 'cytokine storm.'

"ExoFlo does two important things: it remediates the inflammation almost immediately by delivering miRNA that stop the inflammatory cascade, and it delivers growth factors that promote the regeneration of healthy lung tissue for a much speedier recovery."

ExoFlo is manufactured by Direct Biologics, a market-leading cGMP manufacturer of regenerative medical products based in Austin, Texas. ExoFlo has amazed doctors with its ability to fill an unmet but urgent medical need, saving the lives of patients experiencing COVID-19- associated Acute Respiratory Distress Syndrome. Time and again, patients were able to be discharged and returned to their families rather than deteriorating to an irreversible state.

"This product could not have come at a better time," noted Dr. Angel Lazo Jr. of New Jersey. "This product also opens the door to medical solutions forpost-pandemic concerns, when there will be an urgent need to address COVID-19 survivors suffering from Post-Acute COVID Syndrome (PACS), often referred to as long-hauler COVID, and to remediate compromised immune systems and likely lasting pulmonary scarring."

Dr. Sengupta recalls his first experience with ExoFlo: "We were all exhausted, working multiple shifts during the worst of the early days of the epidemic when the New York area was hit so hard. A friend asked me if I could help her elderly parents, both in their 80s and both very ill with COVID-19.The wife had been admitted to the hospital, and unfortunately, despite our best efforts, the hospital administration refused us permission to treat her with ExoFlo.The husband, who had been declining quickly and suffered from a fever, hypoxia, delirium, diarrhea, no sense of taste, and lack of appetite, became the first documented patient in medical history to be administered an exosome-based treatment for critical respiratory illness. He received ExoFlo at home without any adverse reactions and was out of bed and singing arias within two days.Sadly, and unbeknownst to him, his wife had died in the hospital."

This was a dramatic and eye-opening experience. "When I myself fell victim to COVID, I became seriously ill very fast," noted Dr. Sengupta. "I awoke in the middle of the night, struggling to breath and sinking into delirium, and checked my O2sat, immediately realizing I was going into respiratory failure. I called my wife.She left her shift at the hospital, rushed home, and administered ExoFlo. Within 24 hours my supplemental oxygenation requirement, fever, and respiratory symptoms significantly improved. And within five days of that single dose, I was almost fully recovered from the acute infection. I firmly believe that ExoFlo saved my life."

As word spreads within the medical community, increasing numbers of doctors have been astounded by the efficacy and safety of ExoFlo. Among those who have gone on record singing its praises are Dr. Iman Bar of Newport Beach, Calif., and Dr. Jack Mann of Flushing, N.Y.

"The COVID-19 pandemic has presented doctors with a heartbreaking learning curve," said Dr. Sengupta, who has since become Direct Biologic's chief medical officer. "For months we had no choice but to stand by while patients died despite our best efforts to save them. It's an incredible relief now to have ExoFlo in our arsenal of treatments."

ExoFlo is a biopharmaceutical grade regenerative medicine product that represents a meaningful therapy in the fight against the deadly lung inflammation caused by the COVID-19 virus. The new investigational drug uses extracellular vesicles and growth factor proteins isolated from human bone marrow mesenchymal stem cells (MSCs) to reduce inflammation and direct cellular communication capable of strengthening the body's defenses and advancing its healing processes.

ExoFlo is currently in a Phase II clinical trial that expands knowledge gleaned from a prospective, open-label study in which 17 out of 24 patients demonstrated resolution of their ARDS, exhibiting biomarker and oxygenation improvements within 48-72 hours following treatment with a single 15mL intravenous dose of ExoFlo. Since receiving FDA approval of an expanded access protocol in October 2020, ExoFlo is also being utilized by physicians around the country as part of single patient emergency or compassionate use protocol, commonly referred to as eIND.

About Direct Biologics

Direct Biologics, LLC, is headquartered in Austin, Texas, with a recently expanded R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The company was created to expand the science of regenerative healing by delivering cutting-edge biologic technologies. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the company a leader in the evolving, next generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of its extracellular vesicle biologic products through the FDA's investigational new drug application process.

For more information visithttp://www.directbiologics.com.

CONTACT INFORMATION:Tiffany Kayar[emailprotected]

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ExoFlo From Direct Biologics Fulfills Urgent Medical Need in COVID-19 Treatment - PRNewswire

A new SPAC (special purpose acquisition company) play is catching the eyes of investors today. The second half of 2021 looks like it will be filled with hot initial public offerings (IPOs) and SPAC mergers like Robinhood andAurora. Now, anew play will be blending the hype of a new public offering with the pandemic-fed hype toward biotech plays. GX Acquisition (NASDAQ:GXGX) is announcing today their plans to make an attractive biotech outfit public in the newest GXGX merger news.

Source: Shutterstock

GX Acquisition is the newest shell company to take a private entity to market. Today, they are making known their selection in Celularity. Celularity is a New Jersey-based biotechnology outfit that specializes in the treatment of cancer and degenerative diseases. The company takes on these persistent and devastating illnesses by harnessing the power of placenta-based stem cells. Most recently, the company launched its T-cell program, in which it is developing treatments against tumorous growths using mutated placental cells.

Today, GX is happily announcing the closure of its merger with Celularity. The transaction is already paying off well for Celularity; proceeds from the transaction total a cool $138 million. Investors can look forward to Mondays trading session, as Celularity will be taking over on the Nasdaq with the ticker symbol CELU. In the meantime, the GXGX merger is elevating the SPACs stock value.

CEO of GX Dean Kehler is speaking excitedly about Celularitys prospects after seeing a listing. He says the listing will enable Celularity to continue to leverage the companys commercial and clinical stage assets to treat diseases of high unmet need.

Analysts are clamoring ahead of the CELU listing, likeMarket Realist, which called the stem-cell play risky but attractive. Perhaps one of the most appealing aspects of Celularity is its recent partnership with Peter ThielsPalantir Technologies (NYSE:PLTR). The partnership is providing Celularity with fresh cash for furthering its resources. It also ties Celularity to one of the most attractive tech plays on the market right now.

GXGX stock is soaring ahead of the news. The stock is seeing gains of over 34% since the news broke. 15 million shares are exchanging hands today as well, high above GXGXs daily average volume of 313,000.

On the date of publication, Brenden Rearickdid not have (either directly or indirectly) any positions in the securities mentioned in this article.The opinions expressed in this article are those of the writer, subject to the InvestorPlace.comPublishing Guidelines.

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GXGX Merger: The SPAC News That Has GXGX Stock Soaring - InvestorPlace

Company Announcement

Copenhagen, Denmark; June 22, 2021 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis. The EC also approved DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. The approvals follow Positive Opinions by the CHMP of the European Medicines Agency in May 2021. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

AL amyloidosis is a potentially fatal blood disorder for which there is no cure, so we are extremely pleased that patients with AL amyloidosis in Europe may soon have a regimen including DARZALEX SC as a treatment option, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. We are also pleased that, with the approval based on the APOLLO study, the combination of daratumumab with pomalidomide and dexamethasone will now be a treatment option for certain patients with relapsed or refractory multiple myeloma in Europe.

About the ANDROMEDA (AMY3001) studyThe Phase 3 study (NCT03201965) included 416 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About the APOLLO (MMY3013) studyThe Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab. As of Amendment 1 to the study protocol, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was progression free survival (PFS). The study was conducted in Europe under an agreement between Janssen, the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About AL AmyloidosisAmyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure for AL amyloidosis or existing approved therapies for AL amyloidosis patients in Europe, though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that in 2019 there were 4,388 diagnosed incident cases of AL amyloidosis in the five major European markets.2

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.3 Approximately 18,114 new patients were diagnosed with multiple myeloma and approximately 11,063 people died from the disease in the Western Europe in 2020.4 Globally, it was estimated that 176,404 people were diagnosed and 117,077 died from the disease in 2020.5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6

About DARZALEX SC (daratumumab and hyaluronidase-fihj)Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. DARZALEX SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe for the treatment of both multiple myeloma and AL amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 7,8, 9, 10, 11

For the full EU Summary of Product Characteristics, please click here.

About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmabs proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

Contact:Marisol Peron, Senior Vice President, Global Investor Relations & CommunicationsT: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. DARZALEX is a trademark of Johnson & Johnson.

1 Mayo Clinic website: http://www.mayoclinic.com/health/amyloidosis/DS004312 Global Data, Amyloidosis: Epidemiology Forecast to 2029, June 20203 American Cancer Society. "What is Multiple Myeloma." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed May 2021.4 Globocan 2020. Western Europe Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/926-western-europe-fact-sheets.pdf Accessed May 20215 Globocan 2018. World Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf Accessed May 20216 American Cancer Society. "Sings and Symptoms of Multiple Myeloma" https://www.cancer.org/cancer/multiple-myeloma/detection-diagnosis-staging/signs-symptoms.html. Accessed May 20217 DARZALEX Prescribing information, March 2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s033lbl.pdf Last accessed May 20218 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.9 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.10 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.11 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 53CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces that Janssen has Received European - GlobeNewswire

Hear from the CEO of NurExone Biologic Ltd, Israel's promising new start-up which aims to utilize innovative Exosome-based technology and smart delivery platforms in order to revolutionize the way spinal cord injury (SCI) is treated around the world

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June22, 20215 min read

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On Wall Street and prominent global stock exchanges, the emergence of innovative start-up companies has become an Israeli phenomenon. Today, the innovation nation gains unprecedented international recognition as well as investment for a country the size of the (US) state of New Jersey. Based in the northern city of Haifa, one of the newest Israeli startups building upon the countrys profound reputation is NurExone Biologic Ltd. The company, founded just last year, aims to change the way spinal cord injury (SCI) is treated around the world by utilizing exosomes as smart delivery platforms.

Over the past few decades, stem cells have become a significant interest for the scientific community as well as popular culture, and the preliminary results have been incredible. Now, stem cell research and therapy development are at an all-time high with accompanying experimental trials to apply decades of analysis into real-life medicinal practice. In regard to treating SCI, traumatic and non-traumatic, Stem Cells were tested on patients, which some of the patients have benefitted from the use of the stem cells, but due to various challenges, the treatment was not approved yet. However, NurExone promising exosome-based research proof of concept results, shown on animal, has to offer new treatment to SCI patients as well as same potential in traumatic brain injury.

NurExone is led by CEO Dr. Lior Shaltiel, who maintains an impressive background in biotech entrepreneurship, in addition to biomedical engineering, pharmacology and the advancement of smart delivery systems all of which are vital components to the companys mission. The formula behind NurExones solution is a two-prong strategy to concentrate exosome technology as the main fuel and practically treating SCI patients via a smart delivery platform. This combination, which is planned to medically transferred into the body through the nose, has a natural effect in targeting neuron damage. According to Shaltiel, while many companies are using stem cells which release exosomes naturally and attempt to regenerate neurons through local injections, our loaded exosomes have the potential to be transferred into the body nasally which is a considerable game-changer for the industry.

Furthermore, NurExone is equipped with an experienced Board of Directors, including from some of Israels leading pharmaceutical and biotech brands listed on international stock exchanges such as Executive Chairman Ron Mayron of Teva (NYSE: TEVA) and Founder & Director Yoram Drucker of Pluristem (NASDAQ: PSTI) and Brainstorm (BCLI). These substantial decision-makers in the medical technology as well as the Israeli innovation scene is indispensable and attests to the potential of the offer of the company from global operational management to strategic marketing to attracting major investors.

From its inception, NurExones extensive research and ability to conduct experimental testing comes from the companys collaboration with top professors from two of Israels elite universities Technion (noted as Israels MIT) and Tel Aviv University. As part of the companys Co-founders and Scientific Advisory Board, NurExone has partnered with Professor Daniel Offen, Head of Tel Aviv Universitys Neurology Lab, and Professor Shulamit Levenberg, the former Dean of Technions Biomedical Engineering Department and Director of the Technion Center for 3D Bioprinting. The board also features Professor Nashson Knoller, MD, Head of the Neurosurgery Department at Sheba Hospital.

This month, NurExone also implemented notable moves to prepare the company for the subsequent stage developing a promising product for the clinical phase. The company has received important approvals, which allow them to further their developing SCI treatments around the world. This significant advancement in the Israeli start-ups early focus on next stage financial efforts will play a principal role in persuading interested parties and serious investors to the table to help the company progress to become listed on international stock exchanges.

According to Shaltiel, while it usually will take several years for companies during the research and development (R&D) phase to secure investment, we are progressing with our funding model due to the exponential potential of our product. At the moment, NurExones plans to move towards entering the Toronto Stock Venture Exchange (TSXV), a Mecca-like market for penny stocks and new companies attempting to build an investor following for more global exchanges in the future.

In the world of start-up and innovation companies, a companys infrastructure, vision, and basis for research development is crucial to the success and longevity of the business. For NurExone, the companys successful Board of Directors, ambitious and experienced CEO Dr. Lior Shaltiel, together with the Scientific Advisory Board should not merely satisfy these prerequisites but galvanize the biotech community. While the company, after only a few months, has provided an important genesis for potential investors as well as medical professionals to learn from it also shows the teams efficiency and maturity. In order for NurExone to change how SCI is treated around the world, its next pragmatic step will be to analyze and optimize the product to take another step towards making its goal to treat SCI closer to becoming a reality.

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This Startup is Changing the Way Spinal Cord Injury Is Treated Around the World - Entrepreneur