Category Archives: Cell Medicine

They're talking about pain at the $3 billion California stem cell agency. And mortality. But not the end of life as you and I know it.

They're talking about the pain that comes from cutting off millions of dollars for scientists. They're talking about what will happen when the state stops borrowing money to finance stem cell research a final-breath moment that arrives in about five years.

One might think that this is the natural order of business nowadays in California. However, the state's stem cell agency has been the great exception during these troubled financial times.

Thanks to Proposition 71, the agency is well shielded from the state's fiscal typhoons. The 2004 ballot initiative that created the California Institute for Regenerative Medicine, or CIRM as the agency is formally known, also provided a direct stream of state bond cash. The governor and lawmakers cannot legally get their fingers on CIRM's money.

But there are limits. When the bond authorization runs out, CIRM will need more cash. One remote possibility is voter approval of more bonds. The agency, however, is primarily discussing raising money privately and establishing a nonprofit organization.

All this and more will be on the table in one form or another at a meeting Thursday of the CIRM board. It has handed out $1.3 billion so far and is expected to award another $95 million in grants this week. It has only $836 million left for grants. I say "only" because even $836 million goes only so far when the agency ladles out grants in $240 million dollops, as is expected in July.

In a strategic planning document, Ellen Feigal, CIRM's senior vice president for research and development, has laid out its future direction. She said that for the first time CIRM would overtly create 20 programs, with outside investment, that focus on products. Another five-year goal would explicitly call for financing at least 10 therapies in early-phase clinical trials, affecting at least five diseases.

In contrast to the Proposition 71 campaign rhetoric, CIRM's strategic plan acknowledges that developing therapies takes a very long time, often decades.

CIRM's sharper focus is not without fiscal pain. One scenario would mean a $75 million cut in training and shared lab programs cash that helps to finance researchers and that benefits the many institutions that have representation on the CIRM board.

CIRM's changing priorities create "stark tension," said one board member, Michael Friedman, CEO of the City of Hope in the Los Angeles area, in January. "We're going to have to make some really painful and difficult decisions," he told directors.

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In the News: Stem cell cash will run out – then what?

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that it has closed an internal E financing round of $10 million. All major shareholders participated.

The financing will be used to support the global commercialization of the companys lead cell therapy product, StemEx, in development as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor. The company is currently seeking a strategic partner to join in the global commercialization of StemEx.

The financing will also support the continued development of the companys pipeline of products, primarily the NiCord clinical trial for sickle cell disease and thalassemia.

Mr. Reuven Krupik, chairman of the board of Gamida Cell said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer.

The international, multi-center, pivotal registration, Phase III clinical trial of StemEx completed enrollment in February 2012. Clinical outcome is expected in Q4/2012. The market launch of StemEx is planned for 2013. StemEx is likely to be the first allogeneic stem cell product in the market. StemEx is being developed by the Gamida Cell-TEVA joint venture.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, With the continued support of our shareholders and the analysis of the clinical results of the StemEx trial just around the corner, we are now focused on submitting the BLA.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit. Competing products in development use two units. As the average cost of a cord blood unit in the U.S. is $40K, StemEx is expected to be a significantly less expensive treatment option. StemEx is also expected to be available in the market several years before any of the competing products.

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The companys pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, neutropenia and acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cells therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, bone marrow and peripheral blood, which are expanded in culture. Gamida Cells current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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Gamida Cell Closes $10 Million E Financing Round Earmarked to Support the Global Commercialization of the Company’s ...

NEWTON, Mass., May 14, 2012 /PRNewswire/ --Parcell Laboratories, a leading adult stem cell company based in Newton, MA, was awarded the prestigious 2012 Innovation Award by the Smaller Business Association of New England (SBANE). Parcell joins the select list of winning companies from the last 26 years whose innovations have delivered proven value to customers.

SBANE uses its highly competitive Innovation Awards program to showcase technology driven enterprises that are potentially "game changers" in their markets. Parcell's ELA stem cell technology is a platform technology that has unlimited applications for tissue regeneration and is positioned to change the face of regenerative medicine. "We are honored to have been recognized by SBANE for our accomplishments and to be included among the roster of extremely successful companies that have been previous winners of the award," said Pamela Layton, the CEO of Parcell Laboratories. "The award is a testament to the dedication and tenacity of our terrific team." Past award winners include some of the most recognizable names in New England business, including Staples, Genzyme, Ben & Jerry's and Nantucket Nectars.

Parcell Laboratories holds the license and intellectual property to the ELA stem cell, which is considered to be the earliest lineage adult stem cell in the adult body. The cell is able to differentiate into all tissues and has the added benefit of being immune privileged, allowing it to be implanted without the risk of rejection. Parcell's ELA cells are being used by surgeons nationwide to enhance bone regeneration in the aging spine. The product is marketed under the name of PureGen Osteoprogenitor Cell Allograft by Alphatec Spine of Carlsbad, CA. Parcell is also in the development phase of therapeutics using the ELA stem cell for disc and cartilage repair.

Press Contact Susan Kinslow Kinslow@parcelllabs.com +617-928-9803

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Parcell Laboratories Honored as 2012 SBANE Innovation Award Winner

DENVER, May 14, 2012 /PRNewswire/ -- Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences' clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx Physician Network.

Regenerative Sciences' Regenexx procedures utilize a patient's own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.

"We are proud of our accomplishments in the field of regenerative interventional orthopedics and it's exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist," said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. "Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use."

Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.

About Regenerative Sciences

Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: http://www.regenexx.com

About John C. Malone, PhD

Dr. John C. Malone holds a bachelor's degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master's degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.

Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.

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Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

SOUTH SAN FRANCISCO, CA--(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh.

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company's 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model -- to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective -- is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission -- "putting humans first" -- bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.

Sincerely,

Link:
VistaGen CEO Issues Update Letter to Stockholders

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/lffnp7/stem_cell_research) has announced the addition of the "Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)" report to their offering.

Stem cells are primitive cells found in all multi-cellular organisms that are characterized by self-renewal and the capacity to differentiate into any mature cell type. Several broad categories of stem cells exist, including embryonic stem cells, derived from blastocysts; fetal stem cells, obtained from aborted fetuses; adult stem cells, found in adult tissues; cord blood stem cells, isolated from umbilical tissue; dental stem cells, derived from deciduous teeth; cancer stem cells, which give rise to clonal populations of cells that form tumors or disperse in the body; and animal stem cells, derived from non-human sources.

In a developing embryo, stem cells can differentiate into all of the specialized embryonic tissues. In adult organisms, stem and progenitor cells act as a repair system for the body, replenishing specialized cells. Of interest to researchers is the potential for use of stem cells in regenerative medicine to treat conditions ranging from diabetes, to cardiovascular disease and neurological disorders. Additionally, the ability to use stem cells to improve drug target validation and toxicology screening is of intense interest to pharmaceutical companies. Stem cells are also being studied for their ability to improve both the understanding and treatment of birth disorders.

To facilitate research resulting from interest in these far-ranging applications, a large and growing stem cells research products market has emerged. Large companies selling stem cell research products include Life Technologies, BD Biosciences, Thermo Fisher Scientific, and Millipore, although dozens of other suppliers exist as well. Products offered by these companies include: antibodies to stem cell antigens, bead-based stem cell separation systems, stem cell protein purification and analysis tools, tools for DNA and RNA-based characterization of stem cells, stem cell culture and media reagents, stem cell specific growth factors and cytokines, tools for stem cell gene regulation, a range of stem cell services, tools for in vivo and in vitro stem cell tracking, and stem cell lines.

This report explores current market conditions and provides guidance for companies interested in developing strategically positioned stem cell product lines.

Featured elements of this report include:

- What are novel stem cells research products that can be developed?

- What stem cells types are most frequently used by research scientists?

- Which species of stem cells do scientists prefer and what are the factors driving this preference (access, pricing, funding, handling advantages)?

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Research and Markets: Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)

Dr. Julio C. Voltarelli, who made a significant impact in cell transplantation, dies at 63

Distinguished Brazilian professor pioneered bone marrow transplantation

Newswise Tampa, Fla. (May. 9th , 2012) Julio C. Voltarelli, MD, PhD, professor at the Ribeiro Preto School of Medicine at the University of So Paulo, Brazil, died March 21, 2012 at the age of 63. Dr. Voltarelli, who was on the editorial board of the Cell Transplantation journal, published by Cognizant Communication Corporation, and an important factor in the journals success, was a distinguished stem cell researcher and head of the bone marrow transplantation unit at the Ribeiro Preto School of Medicine.

Dr. Voltarelli had a significant impact on Brazilian stem cell transplantation science, said Dr. Maria C. O. Rodrigues, Dr. Voltarellis longtime colleague. He was driven to bring the benefits of the newest cellular therapies to those with ALS, MS and type 1 diabetes. His efforts and dedication will be greatly missed.

Dr. Voltarelli, a graduate of the Ribeiro Preto School of Medicine, served post-doctoral fellowships at the University of California San Francisco, the Fred Hutchinson Cancer Research Center in Seattle, and the Scripps Research Institute in San Diego. He returned to Brazil in 1992 and started a highly ranked bone marrow transplantation program at the Ribeiro Preto School of Medicine. In 2002, Dr. Voltarelli initiated the schools research efforts in stem cell transplantation for autoimmune diseases, later focusing on diabetes, graft-versus-host disease and sickle cell anemia.

At the time of his death, Dr. Voltarelli, in addition to serving as head of the bone marrow transplantation unit, also served as research coordinator for the Center for Cellular Therapy at the So Paulo Research Foundation and the National Institute of Science and Technology in Stem Cells and Cell Therapy. He was recently elected president of the Brazilian Society of Bone Marrow Transplantation.

His publications included the first books on stem cell transplantation and clinical immunology written in Portuguese. He also founded the Brazilian Society of Stem Cell Transplantation.

His colleagues in Brazil called his lifelong contributions priceless and remembered him for his leadership skills, vision, and sense of humor.

# The Coeditor-in-chiefs for CELL TRANSPLANTATION are at the Center for Neuropsychiatry, China Medical University Hospital, TaiChung, Taiwan, and the Diabetes Research Institute, University of Miami Miller School of Medicine. Contact, Shinn-Zong Lin, MD, PhD at shinnzong@yahoo.com.tw or Camillo Ricordi, MD at ricordi@miami.edu or David Eve, PhD at celltransplantation@gmail.com #

News release by Florida Science Communications http://www.sciencescribe.net

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Julio C. Voltarelli, Pioneer in Cell Transplantation, Dies at 63

ScienceDaily (May 10, 2012) This summer's action film, "The Amazing Spider-Man," is another match-up between the superhero and his nemesis the Lizard. Moviegoers and comic book fans alike will recall that the villain, AKA Dr. Curt Connors, was a surgeon who, after losing an arm, experimented with cell generation and reptilian DNA and was eventually able to grow back his missing limb.

The latest issue of the journal Physiology contains a review article that looks at possible routes that unlock cellular regeneration in general, and the principles by which hair and feathers regenerate themselves in particular.

The authors apply what is currently known about regenerative biology to the emerging field of regenerative medicine, which is being transformed from fantasy to reality.

Review Article

While the concept of regenerative medicine is relatively new, animals are well known to remake their hair and feathers regularly by normal regenerative physiological processes. In their review, the authors focus on (1) how extrafollicular environments can regulate hair and feather stem cell activities and (2) how different configurations of stem cells can shape organ forms in different body regions to fulfill changing physiological needs.

The review outlines previous research on the role of normal regeneration of hair and feathers throughout the lifespan of various birds and mammals. The researchers include what is currently known about the mechanism behind this re-growth, as well as what gaps still exist in the knowledge base and remain ripe for future research.

The review examines dozens of papers on normal "physiological regeneration" -- the re-growth that happens over the course of an animal's life and not in response to an injury. This regeneration takes place to accommodate different stages in an animal's life (e.g., replacing downy chick feathers with an adult chicken's, or replacing the fine facial hair of a young boy with the budding beard of an adolescent), or in response to various environmental conditions (e.g., cats shedding a thick winter coat in the summer heat but re-growing it when the seasons change again, or snowshoe hares switching from brown in the summer to white in the winter for camouflage).

These changes seem to respond both to internal cues such as physiology of the hair follicle itself, or external cues such as the environment, but the mechanisms behind these normal alterations are largely unknown. Stem cells inside the follicle prompt hair and feather regeneration, but researchers are still unsure how to guide those cells to form the shape, size, and orientation of these "skin appendages" so that controlled re-growth is possible. Additionally, scientists are still unsure how to re-grow hair on skin in people after severe injuries that lead to scar tissue.

Importance of the Findings

The reviewed studies suggest that while researchers are making headway in understanding how and why hair and feathers regenerate after normal loss or in response to different life stages, much still remains unknown. This missing knowledge could hold valuable clues to learning how to regenerate much more complicated and valuable structures after loss to injury, such as fingers and toes.

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Regenerative medicine: Could the ways animals regenerate hair and feathers help restore human fingers and toes?

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG - News), today announced that results from three phase III studies evaluating the use of continuous REVLIMID (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas.

Continuous Lenalidomide Therapy (non-transplant eligible population):

The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma.

Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015)

This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalanprednisonelenalidomide induction followed by lenalidomide maintenance (MPR-R), with melphalanprednisonelenalidomide (MPR), or melphalanprednisone (MP) followed by placebo in 459 patients aged 65 years with newly-diagnosed myeloma who were not eligible for autologous stem-cell transplant.

http://www.nejm.org/doi/full/10.1056/NEJMoa1112704

Post-transplant maintenance

The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT).

In each of the studies, one funded by the National Cancer Institute and conducted by the Cancer and Leukemia Group B (CALGB) and one by the Intergroupe Francophone du Myelome (IFM), maintenance treatment with lenalidomide following ASCT resulted in delayed time to disease progression or death compared to placebo.

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New England Journal of Medicine Reports on Three Phase III REVLIMID® (lenalidomide) Trials in Patients with Newly ...

9 May 2012 Last updated at 14:14 ET By James Gallagher Health and science reporter, BBC News

It may be possible to use "stem cell shielding" to protect the body from the damaging effects of chemotherapy, early results from a US trial suggest.

Chemotherapy drugs try to kill rapidly dividing cancer cells, but they can also affect other healthy tissues such as bone marrow.

A study, in Science Translational Medicine, used genetically modified stem cells to protect the bone marrow.

Cancer Research UK said it was a "completely new approach".

The body constantly churns out new blood cells in the hollow spaces inside bone. However, bone marrow is incredibly susceptible to chemotherapy.

The treatment results in fewer white blood cells being produced, which increases the risk of infection, and fewer red blood cells, which leads to shortness of breath and tiredness.

Researchers at the Fred Hutchinson Cancer Research Center, in Seattle, said these effects were "a major barrier" to using chemotherapy and often meant the treatment had to be stopped, delayed or reduced.

They have tried to protect the bone marrow in three patients with a type of brain cancer, glioblastoma.

One of the researchers, Dr Jennifer Adair, said: "This therapy is analogous to firing at both tumour cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumour cells are unshielded."

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'Cell shield' for cancer patients