Category Archives: Cell Medicine

On March 8-9 in Boston, stem cell medicine biotechnology start-up Asymmetrex led attendees at the 6th Annual Clinical Trials Supply New England 2017 conference in discussions about the need for quality controls for the supply of tissue stem cells used for treatments in either FDA-approved clinical trials or unregulated private stem cell clinics. Though these two stem cell treatment settings are often contrasted regarding their safety and effectiveness, Asymmetrex stressed that patient care and research progress is compromised in both because of the lack of essential quality control tests for the number and quality of transplanted tissue stem cells.

Boston, MA (PRWEB) March 14, 2017

At the 6th Annual Clinical Trials Supply New England 2017 conference, held in Boston from March 8-9, James Sherley, M.D., Ph.D., director of Asymmetrex, led discussions that evaluated the quality of U.S. supplies of stem cells used in clinical trials compared to private stem cell clinics. Private stem cell clinics have been criticized for not employing research standards that are necessary to establish the therapeutic effectiveness of treatments with statistical confidence. In part because of this difference in practice, they are also often accused of making unproven claims about the effectiveness of their therapies.

Sherley presented comparisons of key operational elements to argue that, given good intent in both settings, the two different settings of stem cell treatments had both distinct and shared shortcomings. He noted, however, that the most significant shortcoming, which stem cell clinical trials and private stem cell clinics share, was perennially overlooked.

Based on the number of reported stem cell clinical trials and private stem cell clinics, Sherley estimated that close to a quarter-million patients in the U.S. now receive stem cell treatments each year. Though many of these occur within FDA-approved clinical trials, their number is dwarfed nearly 10 times by the number of treatments that occur in private stem cell clinics. It shocked the audience of clinical trial suppliers to learn that there was no stem cell quality control test performed for any of these many treatments.

Even for approved stem cell medicine treatments like bone marrow transplantation and umbilical cord blood transplant, there is no stem cell-specific quality control test available. Counts of total cells are made, but these do not adequately predict stem cell number or function. Biomarkers designated for tissue stem cells are also expressed by stem cells' more abundant non-stem cell products. So, the biomarkers lack sufficient specificity to be used to count and monitor tissue stem cell function.

Without a quality control test for tissue stem cell number, stem cell treatments in all settings proceed without knowing the dose of treating tissue stem cells. This previously unavoidable therapeutic blind spot creates an instant treatment risk. It also precludes effective analyses to optimize treatment procedures, to compare different treatments, or to relate treatment outcomes to tissue stem cell dose. Without knowing stem cell dose, the interpretation of any stem cell treatment in terms of stem cells as the responsible agents is compromised.

In this context, Sherley announced briefly to attendees that Asymmetrex's new AlphaSTEM Test for counting adult tissue stem cells and providing data on their viability and tissue cell renewal function represented the needed first quality control test for tissue stem cell treatments, whether in clinical trials, in private stem cell clinics, or approved therapies. In particular, he indicated that both stem cell treatment patients and progress in stem cell medicine would benefit from existing clinical trial supply companies developing into future private stem cell clinic supply companies to insure the quality of stem cell treatment preparations. Sherley said that, of course, their partnership with Asymmetrex to implement its new stem cell-specific quality control test was an all around best solution for accelerating progress in stem cell transplantation medicine.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrex's founder and director, James L. Sherley, M.D., Ph.D. is an internationally recognized expert on the unique properties of adult tissue stem cells. The company's patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Currently, Asymmetrex's focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

For the original version on PRWeb visit: http://www.prweb.com/releases/2017/03/prweb14146903.htm

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At 6th Annual Clinical Trial Supply New England 2017 Conference in Boston Asymmetrex Introduces A First Specific ... - Benzinga

The most exciting aspect of our findings is that no matter what kind of brain tumor we tested it against, this treatment worked really well in the animal models, said Cheshier, who is also a pediatric neurosurgeon at Lucile Packard Childrens Hospital Stanford. In mice that had been implanted with both normal human brain cells and human brain cancer cells, there was no toxicity to normal human cells but very, very active tumor-killing in vivo, he said.

Given the encouraging results of the new study and the ongoing research on anti-CD47 antibodies in adults, the antibodies are expected to reach clinical trials in children with brain cancer in one to two years, he added.

The anti-CD47 antibodies help the immune system to detect an important difference between cancerous and healthy cells: Cancer cells make eat me signals that are displayed on their cell surfaces, while healthy cells do not. However, cancer cells hide these eat me signals by producing large quantities of CD47, a dont eat me protein that is found on the surface of both healthy and malignant cells. When CD47 is blocked by antibodies, immune cells called macrophages can detect the cancer cells eat me signals. Macrophages then selectively target, engulf and destroy the cancer cells without harming healthy cells, because normal cells lack the eat me signals.

The Stanford team conducted a long series of experiments using different combinations of tumor cells and healthy cells in culture, as well as in various mouse models in which human brain cancer cells had been implanted in mice. Highlights of their experiments included the following:

The anti-CD47 antibodies did not completely eliminate all tumors, suggesting that the antibodies may not be able to completely penetrate large tumors, the researchers noted.

To maximize their effects, the antibodies will likely need to be combined with other forms of cancer treatment, a concept the researchers plan to investigate further, Cheshier said. In the future, patients may receive combinations of immune therapies and lower doses of standard cancer treatments, he said, adding, The question is: Can we wisely combine immune therapies and other approaches to make cancer treatment more efficacious and less toxic?

Anti-CD47 antibodies also may have an advantage over other immunotherapies in that they activate macrophages, which completely engulf and eat cancer cells, Cheshier noted. In many forms of immunotherapy, the cells you target die and spill their contents, which can cause dysregulated immune responses, he said. Anti-CD47 antibodies may produce fewer such side effects, though the idea remains to be tested.

Other Stanford co-authors of the paper are medical students Abdullah Feroze, Rogelio Esparza and Michael Zhang; postdoctoral scholars Suzana Kahn, PhD, Anne Volkmer, MD and Stephen Willingham, PhD; research assistants Anitha Ponnuswami, Theresa Storm, Cyndhavi Narayanan and Pauline Chu; senior research associate Jie Liu, MD, PhD; undergraduate research associate Chase Richard; Aaron McCarthy, a former life sciences research professional and animal colony manager; Patricia Lovelace, research and development engineer; Simone Schubert, life science researcher; visiting scholar Gregor Hutter, MD, PhD; Griffith Harsh, MD, professor of neurosurgery; Michelle Monje, MD, PhD, assistant professor of neurology; Yoon-Jae Cho, MD, a former assistant professor of neurology and neurological sciences; Ravi Majeti, MD, PhD, associate professor of medicine; senior scientist Jens Volkmer, MD; Paul Fisher, MD, professor of pediatrics; Gerald Grant, MD, associate professor of neurosurgery; Gary Steinberg, MD, PhD, professor of neurosurgery; Hannes Vogel, MD, professor of pathology and of pediatrics; and Michael Edwards, MD, professor of neurosurgery.

Cheshier, Monje, Majeti, Fisher, Grant and Edwards are members of Stanfords Child Health Research Institute. Cheshier, Weissman, Harsh, Monje, Majeti, Fisher, Grant, Vogel and Edwards are members of the Stanford Cancer Institute. Weissman is the director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine and of the Ludwig Center for Cancer Stem Cell Research and Medicineat Stanford.

Scientists from SickKids, the Hospital for Sick Children in Toronto; University Hospital, Dusseldorf; and Johns Hopkins University also contributed to the study.

The study was funded by National Institute of Neurological Disorders and Stroke (grant NINDSK08NS070926); the National Cancer Institute (grant P30CA006973); the California Institute for Regenerative Medicine; the Price Family Charitable Fund; the Center for Childrens Brain Tumors at Stanford; St. Baldricks Foundation; the American Brain Tumor Foundation; the Seibel Stem Cell Institute; the Pew Charitable Trusts; the Dr. Mildred-Scheel Foundation/German Cancer Aid; the German Research Foundation; the McKenna Claire Foundation; the Matthew Larson Foundation; Alexs Lemonade Stand Foundation; The Cure Starts Now; the Lyla Nsouli Foundation; the Dylan Jewett, Connor Johnson, Zoey Ganesh, Dylan Frick, Abigail Jensen, Wayland Villars and Jennifer Kranz memorial funds; the Virginia and D. K. Ludwig Fund for Cancer Research; the Lucile Packard Foundation for Childrens Health; the National Institutes of Health (grant UL1TR001085); the Tashia and John Morgridge Endowed Pediatric Faculty Scholar and Fellowships Awards; and the Anne T. and Robert M. Bass Endowed Faculty Scholarship in Pediatric Cancer and Blood Diseases. The study was also funded by gifts from George Landegger; Rider and Victoria McDowell; Charles Comey and Judith Huang; and Colin and Jenna Fisher.

Stanfords Department of Neurology & Neurological Sciences also supported the work.

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Antibody fights pediatric brain tumors in preclinical testing | News ... - Stanford Medical Center Report

Scientists from the University of Cambridge have determined the first 3D structures of mammalian genomes from individual cells.

For the first time, researchers from the University of Cambridge were able to determine the 3D structure of an active mouse genome in embryonic stem cells. Tim Stevens and his colleagues used a combination of imaging and measurements that reveal DNA interactionsto unravel how the DNA is folded together.This could lead tonew insights into the regulation of gene expression in health and disease.

Every cell in our body contains the same DNA molecules and thusthe same set of genes. Still,our blood cells differ fundamentally from our skin cells. The basis for this isgene regulation, meaning that different cells will not express every gene encoded on our DNA but only a specific subset.

An exciting new avenue for our understanding of gene regulation is the importance of the 3D DNA structure. Regulatory regions within our DNA play a major role in regulating gene expression, but arequirement is that the regions come into spatial contact with the associated genes.

It is well known today, that the way the DNA is folded within the cell is tightlyregulated and determines the contact between different regulatory regions with different genes and thereby determines which genes areswitched on or off.

By looking at individual stem cells, the researchers willnow be able to better understandhowthese master cells are able to differentiate into different cell types of our body, which could revolutionize regenerative medicine.

Knowing where all the genes and control elements are at a given moment will help us understand the molecular mechanisms that control and maintain their expression. () Currently, these mechanisms are poorly understood and understanding them may be key to realizingthe potential of stem cells in medicine.says Prof Ernest Laue, who supervised the study.

A better understanding of how the genome structure determines whether genes are switched on or off could also be important to understand what happens in cancer. Abnormal genomes might cause changes in DNA folding and thereby lead to abnormal gene expression.

Changes in gene expression which are not based on the DNA sequence are calledepigenetic modifications. Epigenetics is definitely one of the recent hypes within the cancer field.The folding of DNA is only one aspect of epigenetic gene regulation, while direct modifications of the DNA or DNA-associated proteins provide another. Cancer cells often make use of the epigenetic machinery to change gene regulation and support their survival.

A recent study,for example, unveiled the role of epigenetic changes in driving pancreatic cancer metastasis. By understanding what happens on the gene regulatorylevel, the researchers were able to find a compound, which specifically inhibits these epigenetic changes and therebycancer cell progression.

Epigenetic mechanisms definitely play a key role not only to advance our understanding of stem cell commitment and regenerative medicine, but also in disease areas such as cancer research. You can findthe identified 3D structures of the DNA below.

Images via shutterstock.com /Iaremenko Sergii

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The First 3D DNA Structure could advance Stem Cell Therapies - Labiotech.eu (blog)

March 14, 2017

An international research team, led by scientists at University of California San Diego School of Medicine, has created the first cellular model of anorexia nervosa (AN), reprogramming induced pluripotent stem cells (iPSCs) derived from adolescent females with the eating disorder.

Writing in the March 14th issue of Translational Psychiatry, the scientists said the resulting AN neuronsthe disease in a dishrevealed a novel gene that appears to contribute to AN pathophysiology, buttressing the idea that AN has a strong genetic factor. The proof-of-concept approach, they said, provides a new tool to investigate the elusive and largely unknown molecular and cellular mechanisms underlying the disease.

"Anorexia is a very complicated, multifactorial neurodevelopmental disorder," said Alysson Muotri, PhD, professor in the UC San Diego School of Medicine departments of Pediatrics and Cellular and Molecular Medicine, director of the UC San Diego Stem Cell Program and a member of the Sanford Consortium for Regenerative Medicine. "It has proved to be a very difficult disease to study, let alone treat. We don't actually have good experimental models for eating disorders. In fact, there are no treatments to reverse AN symptoms."

Primarily affecting young female adolescents between ages 15 and 19, AN is characterized by distorted body image and self-imposed food restriction to the point of emaciation or death. It has the highest mortality rate among psychiatric conditions. For females between 15 and 24 years old who suffer from AN, the mortality rate associated with the illness is 12 times higher than the death rate of all other causes of death.

Though often viewed as a non-biological disorder, new research suggests 50 to 75 percent of risk for AN may be heritable; with predisposition driven primarily by genetics and not, as sometimes presumed, by vanity, poor parenting or factors related to specific groups of individuals.

But little is actually known about the molecular, cellular or genetic elements or genesis of AN. In their study, Muotri and colleagues at UC San Diego and in Brazil, Australia and Thailand, took skin cells from four females with AN and four healthy controls, generated iPSCs (stem cells with the ability to become many types of cells) from these cells and induce these iPSCs to become neurons.

(Previously, Muotri and colleagues had created stem cell-derived neuronal models of autism and Williams syndrome, a rare genetic neurological condition.)

Then they performed unbiased comprehensive whole transcriptome and pathway analyses to determine not just which genes were being expressed or activated in AN neurons, but which genes or transcripts (bits of RNA used in cellular messaging) might be associated with causing or advancing the disease process.

No predicted differences in neurotransmitter levels were observed, the researchers said, but they did note disruption in the Tachykinin receptor 1 (TACR1) gene. Tachykinins are neuropeptides or proteins expressed throughout the nervous and immune systems, where they participate in many cellular and physiological processes and have been linked to multiple diseases, including chronic inflammation, cancer, infection and affective and addictive disorders.

The scientists posit that disruption of the tachykinin system may contribute to AN before other phenotypes or observed characteristics become obvious, but said further studies employing larger patient cohorts are necessary.

"But more to the point, this work helps make that possible," said Muotri. "It's a novel technological advance in the field of eating disorders, which impacts millions of people. These findings transform our ability to study how genetic variations alter brain molecular pathways and cellular networks to change risk of ANand perhaps our ability to create new therapies."

Explore further: Stem cell-derived 'mini-brains' reveal potential drug treatment for rare disorder

More information: P D Negraes et al, Modeling anorexia nervosa: transcriptional insights from human iPSC-derived neurons, Translational Psychiatry (2017). DOI: 10.1038/tp.2017.37

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An international research team, led by scientists at University of California San Diego School of Medicine, has created the first cellular model of anorexia nervosa (AN), reprogramming induced pluripotent stem cells (iPSCs) ...

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Excerpt from:
Researchers create model of anorexia nervosa using stem cells - Medical Xpress

Some heritable but unstable genetic mutations that are passed from parent to affected offspring may not be easy to investigate using current human-induced pluripotent stem cell (hiPSC) modeling techniques, according to research conducted at The Icahn School of Medicine at Mount Sinai. The study serves to caution stem cell biologists that certain rare mutations, like the ones described in the study, are difficult to recreate in laboratory-produced stem cells.

Stem cell-based disease modeling involves taking cells from patients, such as skin cells, and introducing genes that reprogram the cells into human-induced pluripotent stem cells (hiPSCs). These master cells are unspecialized, meaning they can be pushed to become any type of mature cell needed for research, such as skin, liver or brain. The hiPSCs are capable of renewing themselves over a long period of time, and this emerging stem cell modeling technique is helping elucidate the genetic and cellular mechanisms of many different disorders.

Our study describes how a complex chromosomal rearrangement genetically passed by a patient with psychosis to her affected son was not well recreated in laboratory-produced stem cells, says Kristen Brennand, PhD, Associate Professor of Genetics and Genomic Sciences, Neuroscience, and Psychiatry at the Icahn School of Medicine, and the studys senior investigator. As stem cell biologists dive into studying brain disorders, we all need to know that this type of rare mutation is very hard to model with induced stem cells.

To investigate the genetic underpinnings of psychosis, the research team used hiPSCs from a mother diagnosed with bipolar disease with psychosis, and her son, diagnosed with schizoaffective disorder. In addition to the normal 46 chromosomes (23 pairs), the cells in mother and son had a very small extra chromosome, less than 1/10th normal size. This microduplication of genes is increasingly being linked to schizophrenia and bipolar disorders, and the extra chromosomal bit, known as a marker (mar) element, falls into the category of abnormally duplicated genes.

For the first time, the Mount Sinai research team tried to make stem cells from adult cells with this type of mar defect. Through the process, they discovered that the mar element was frequently lost during the reprogramming process.

While mar elements in the general population are rare (less than .05 percent in newborn infants), more than 30 percent of individuals with these defects are clinically abnormal, and mar elements are also significantly more likely to be found in patients with developmental delays.

The study found that the mothers cells were mosaic, meaning some cells were normal while others were not, and the hiPSCs the team created accurately replicated that condition: some were normal and some had the extra mar chromosome. But the technique did not work well with the sons cells. While all of his cells should have had the mar element, as with his mother, some of the reprogrammed stem cells did not contain the extra bit of chromosome.

We realized we kept losing the mutation in the stem cells we made, and the inability to recreate cells with mar elements may hamper some neuropsychiatric research, says Dr. Brennand. The bottom line is that it is essential that stem cell biologists look for existing mar elements in the cells they study, in order to check that they are retained in the new stem cells.

Reference:

Tcw, J., Carvalho, C. M., Yuan, B., Gu, S., Altheimer, A. N., Mccarthy, S., . . . Brennand, K. J. (2017). Divergent Levels of Marker Chromosomes in an hiPSC-Based Model of Psychosis. Stem Cell Reports. doi:10.1016/j.stemcr.2017.01.010

This article has been republished frommaterialsprovided by Mount Sinai Hospital. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Stem Cell-based Modelling can be Difficult for Rare Genetic Variants - Technology Networks

Cancer is currently one of the top killers worldwide, and the number of cancer cases is only expected to rise. Although there are a number of therapies available, most of them are toxic and cause serious side effects. New research examines the impact of the natural vitamin C on cancer cell growth.

Cancer is the second leading cause of death and disease worldwide, accounting for almost 9 million deaths in 2015, according to the World Health Organization (WHO).

The global number of new cases of cancer are expected to grow by around 70 percent in the next 20 years.

In the United States, the National Cancer Institute (NCI) estimate that almost 40 percent of U.S. men and women will have developed cancer at one point during their lives.

There are various treatment options available for cancer, but they are not always effective; most of them are toxic, and they tend to have a variety of side effects.

In some more aggressive cases, the cancer does not respond to treatment, and it is believed that cancer stem-like cells are the reason why the cancer comes back and metastasizes.

New research, published in the journal Oncotarget, examines the effectiveness of three natural substances, three experimental drugs, and one clinical drug in stopping the growth of these cancer stem cells (CSCs.)

The study was conducted by researchers from the University of Salford in Manchester in the United Kingdom, and was led by Dr. Gloria Bonuccelli.

In total, the researchers measured the impact of seven substances: the clinical drug stiripentol, three experimental drugs (actinonin, FK866, and 2-DG), and three natural substances (caffeic acid phenyl ester (CAPE), silibinin, and ascorbic acid (vitamin C).)

The research focused on the bioenergetic processes of CSCs, which enable the cells to live and multiply. The study aimed to disrupt the CSCs' metabolism and ultimately prevent their growth.

Of all the substances tested, the team found that actinonin and FK866 were the most effective. However, the natural products were also found to prevent the formation of CSCs, and vitamin C was 10 times more effective than the experimental drug 2-DG.

Additionally, the study revealed that ascorbic acid works by inhibiting glycolysis - the process by which glucose is broken down within the cell's mitochondria and turned into energy for the cell's proliferation.

Dr. Michael P. Lisanti, professor of translational medicine at the University of Salford, comments on the findings:

"We have been looking at how to target cancer stem cells with a range of natural substances including silibinin (milk thistle) and CAPE, a honey-bee derivative, but by far the most exciting are the results with vitamin C. Vitamin C is cheap, natural, nontoxic and readily available so to have it as a potential weapon in the fight against cancer would be a significant step."

"This is further evidence that vitamin C and other nontoxic compounds may have a role to play in the fight against cancer," says the study's lead author.

"Our results indicate it is a promising agent for clinical trials, and as an add-on to more conventional therapies, to prevent tumor recurrence, further disease progression, and metastasis," Bonuccelli adds.

Vitamin C has been shown to be a potent, nontoxic, anticancer agent by Nobel Prize winner Linus Pauling. However, to the authors' knowledge, this is the first study providing evidence that ascorbic acid can specifically target and neutralize CSCs.

Learn how 300 oranges' worth of vitamin C can impair cancer cells.

Read more here:
Vitamin C can target and kill cancer stem cells, study shows ... - Medical News Today

US Stem Cell Inc (OTCMKTS:USRM) is a penny player in the stem cell space that recently caught some major air off the pattern lows. We looked at this stock a couple weeks ago, and suggested some theories about the movement, finding no clear signs that USRM stock was being openly pushed by investor awareness activity. Instead, we hypothesized that the blast off was related to the potential amicable settlement of a legal matter withNorthStar Biotech.

At this point, shares are consolidating the recent advance, and the company has come out with some news clarifying things a bit, recently announcing that Greg Knutson, the Manager of NorthStar Biotech, LLC, has joined the Board of Directors of U.S. Stem Cell, Inc. That is particularly interesting given our hypothesis in our last piece. It would appear this announcement suggests we were correct in our framing.

US Stem Cell Inc (OTCMKTS:USRM) trumpets itself as a company committed to the development of effective cell technologies to treat a variety of diseases and injuries. By harnessing the bodys own healing potential, we may be able to reverse damaged tissue to normal function.

U.S. Stem Cells discoveries include multiple cell therapies in various stages of development that repair damaged tissues throughout the body due to injury or disease so that patients may return to a normal lifestyle.

U.S Stem Cell is focused on regenerative medicine. While most stem cell companies use one particular cell type to treat a variety of diseases, U.S Stem Cell utilizes various cell types to treat different diseases. It is our belief that the unique qualities within the various cell types make them more advantageous to treat a particular disease.

According to company materials, US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.

Find outwhen $USRM stock reaches critical levels. Subscribe to OracleDispatch.com Right Now by entering your Email in the box below.

As we noted last time, there is very little clear information out there to be found on the details of the legal matter between NorthStar Biotech, LLC, and US Stem Cell Inc. However, managements perspective on things offers at least some clue as to how this development fits into the larger picture.

We are very pleased that Greg Knutson, a longtime supporter of the U.S. Stem Cell family of companies, has agreed to join our Board and assist us to continue with our recent technological advances and financial accomplishments, said Mike Tomas, President and CEO of U.S. Stem Cell, Inc. A longtime U.S. Stem Cell shareholder and supporter, Knutson brings more than 30 years of business and financial experience to the organization. During his entrepreneurial career, Knutson founded Concrete Specialists, Inc. and continues to serve as its President; is the founder and current President of Sunwood Properties; and is the founder and Managing Partner of G&G Land Development, LLC.

The release continues to state matters more plainly: Demonstrating a progressive step forward, Knutson joins the Board of Directors just as the two companies amicably settled a legal dispute related to NorthStars preferred shares.

Weve witnessed in excess of 550% piled on for shareholders of the listing during the trailing month, a bounce that has taken root amid largely bearish action over the larger time frame. The situation may be worth watching. USRM has a history of dramatic rallies. Moreover, the listing has benefitted from a jump in recent trading volume to the tune of approaching 500% over the long run average.

US Stem Cell has a chunk ($246K) of cash on the books. But that total must be weighed against a mountain of about $3.3M in total current liabilities. One should also note that debt has been steadily growing over recent quarters. USRM is pulling in trailing 12-month revenues of $2.7M. In addition, the company is seeing major top line growth, with y/y quarterly revenues growing at 30.9%. Given the volume and volatility now involved, this may be a very interesting story and we will look forward to updating it again soon. For continuing coverage on shares of $USRM stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!

Read more:
More Clarity Emerges on US Stem Cell Inc (OTCMKTS:USRM) - The Oracle Dispatch

March 13, 2017

Some heritable but unstable genetic mutations that are passed from parent to affected offspring may not be easy to investigate using current human-induced pluripotent stem cell (hiPSC) modeling techniques, according to research conducted at The Icahn School of Medicine at Mount Sinai and published March 14, in the journal Stem Cell Reports. The study serves to caution stem cell biologists that certain rare mutations, like the ones described in the study, are difficult to recreate in laboratory-produced stem cells.

Stem cell-based disease modeling involves taking cells from patients, such as skin cells, and introducing genes that reprogram the cells into human-induced pluripotent stem cells (hiPSCs). These "master cells" are unspecialized, meaning they can be pushed to become any type of mature cell needed for research, such as skin, liver or brain. The hiPSCs are capable of renewing themselves over a long period of time, and this emerging stem cell modeling technique is helping elucidate the genetic and cellular mechanisms of many different disorders.

"Our study describes how a complex chromosomal rearrangement genetically passed by a patient with psychosis to her affected son was not well recreated in laboratory-produced stem cells," says Kristen Brennand, PhD, Associate Professor of Genetics and Genomic Sciences, Neuroscience, and Psychiatry at the Icahn School of Medicine, and the study's senior investigator. "As stem cell biologists dive into studying brain disorders, we all need to know that this type of rare mutation is very hard to model with induced stem cells."

To investigate the genetic underpinnings of psychosis, the research team used hiPSCs from a mother diagnosed with bipolar disease with psychosis, and her son, diagnosed with schizoaffective disorder. In addition to the normal 46 chromosomes (23 pairs), the cells in mother and son had a very small extra chromosome, less than 1/10th normal size. This microduplication of genes is increasingly being linked to schizophrenia and bipolar disorders, and the extra chromosomal bit, known as a marker (mar) element, falls into the category of abnormally duplicated genes.

For the first time, the Mount Sinai research team tried to make stem cells from adult cells with this type of mar defect. Through the process, they discovered that the mar element was frequently lost during the reprogramming process.

While mar elements in the general population are rare (less than .05 percent in newborn infants), more than 30 percent of individuals with these defects are clinically abnormal, and mar elements are also significantly more likely to be found in patients with developmental delays.

The study found that the mother's cells were mosaic, meaning some cells were normal while others were not, and the hiPSCs the team created accurately replicated that condition: some were normal and some had the extra mar chromosome. But the technique did not work well with the son's cells. While all of his cells should have had the mar element, as with his mother, some of the reprogrammed stem cells did not contain the extra bit of chromosome.

"We realized we kept losing the mutation in the stem cells we made, and the inability to recreate cells with mar elements may hamper some neuropsychiatric research," says Dr. Brennand. "The bottom line is that it is essential that stem cell biologists look for existing mar elements in the cells they study, in order to check that they are retained in the new stem cells."

Explore further: Researchers engineer new thyroid cells

Researchers have discovered a new efficient way to generate thyroid cells, known as thyrocytes, using genetically modified embryonic stem cells.

A protein that stays attached on chromosomes during cell division plays a critical role in determining the type of cell that stem cells can become. The discovery, made by EPFL scientists, has significant implications for ...

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Scientists have determined the first 3D structures of intact mammalian genomes from individual cells, showing how the DNA from all the chromosomes intricately folds to fit together inside the cell nuclei.

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Some genetic variations difficult to evaluate using current stem cell modeling techniques - Phys.Org

chairoij/ShutterStockImagine having your spleen removed, undergoing a double hip replacement, and receiving monthly blood transfusions to prevent severe pain attacks, all by the age of 13. That was the life of a teenager in France with sickle cell disease (SCD) until October 2014, when he received experimental gene therapy as part of a clinical study. Now, hes completely off all medications and his SCD is essentially gone, making him the hopeful poster child for the worlds first effective sickle cell disease therapy. (Dont these medical miracles that doctors cant explain.)

Standard treatments were not able to control his SCD symptoms [but] since receiving the stem cell transplant with LentiGlobin, he has been free from severe symptoms and has resumed normal activities, without the need for further transfusions, said study author Marina Cavazzana, MD, PhD, of Necker Hospital in Paris, France, where the trial was conducted, in a news release.

SCD is a inherited blood disorder where sufferers have sickle hemoglobin, an abnormal form of the oxygen-carrying protein which changes the shape of red blood cells (from a flexible disc shape to a rigid crescent one), making it hard for them to pass through blood vessels and often causing blockages that slow or stop the flow of oxygen-rich blood to nearby tissues, causing sudden and severe pain. Sickled red blood cells also die after 10 to 20 days, compared to normal ones which can live up to 120; this can cause the body to have trouble keeping up with red blood cell production, leading to anemia. A stem-cell transplant is currently the only curative option for patients, but fewer than 18 percent of patients are able to find a matching donor.

That is until now. The 13-year-old boy (known as Patient 1204) had bone marrow extracted, which was then genetically altered with the drug LentiGlobin BB305 so that his body made normal, healthy red blood cells instead of the sickle cells it was creating before. After just six months, the proportions of sickled red cells in his blood were significantly lower than those in untreated SCD patients. Now more than 15 months since the treatment, his body is still producing normal red blood cells and he hasnt experience any SCD-related episodes or hospitalizations, according to the study published in the New England Journal of Medicine.

Ive worked in gene therapy for a long time and we make small steps and know theres years more work. But here you have someone who has received gene therapy and has complete clinical remissionthats a huge step forward, Deborah Gill, PhD, of the gene medicine research group at the University of Oxford in England told BBC.

Scientists plan to test the drug on other sickle cell disease patients to see if the results are replicated.

MORE: This Grandmother Beat Cancer in a Groundbreaking 20-Minute Treatment

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Teen's Sickle Cell Disease 'Reversed' with Groundbreaking Therapy - Reader's Digest

The Regenerative Medicine Workshop at Hilton Head began its third decade with a long and diverse lineup of researchers who presented their latest work on a spacious range of topics, from DNA barcoded technology to strategies to reverse tissue degeneration in rotator cuff injuries.

In other words, the usual dizzying array of up-to-the-minute research from some of the worlds leading scientists and engineers.

But if there was a topical theme to last weeks 21st annual workshop (March 1-4), it was immunology.

The Hilton Head summit has always been a place where you can learn about the great, late breaking innovations in regenerative medicine, says Ned Waller, professor in the Emory University School of Medicine, and a researcher with the Petit Institute for Bioengineering and Bioscience at Georgia Tech. What striking this year is, half the talks are about immunology.

And that suits Waller just fine. He is director of the Division of Stem Cell Transplantation and Immunotherapy at the Winship Cancer Institute of Emory, where he also directs the Bone Marrow and Stem Cell Transplant Center. And his research presentation at Hilton Head was entitled, Another Arrow in the Anti-cancer Quiver: VIP Immunotherapy.

Waller also is one of three co-directors of the Regenerative Engineering and Medicine (REM) research center, a consortium of research institutes in Georgia: Emory, Georgia Tech, and the University of Georgia. REM is one of four organizing partners of the workshop, the others being the Stem Cell and Regenerative Medicine Center at the University of Wisconsin, the Mayo Clinics Center for Regenerative Medicine, and the McGowan Institute for Regenerative Medicine at the University of Pittsburgh.

Accordingly, faculty, post-doctoral, and student researchers from those institutions were well represented. But the workshop also drew researchers from across the spectrum and the planet. Among the speakers were Ronald Germain from the National Institutes of Health, and Molly Stevens from Imperial College in London. Rolando Gittens, who earned his Ph.D. in bioengineering at Georgia Tech in 2012 and is now a research scientist at the Institute for Scientific Research and High Technology Services of Panama.

There were also deep-dive presentations from researchers based at Duke, Harvard, Tufts, and Yale universities, among others, and Jeff Hubbell, the Nerem Lecturer from the University of Chicago (who delivered a talk on Biomolecular Engineering in Regenerative Medicine and Immunotherapies).

Steve Stice, as co-director of the REM from the University of Georgia (UGA), the newest member of the consortium, appreciated the geographic range of work that was presented.

One of the nice things this years is that UGA and other institutions are well represented, says Stice, professor and director of the Regenerative Bioscience Center at UGA and a Petit Institute researcher. So its not just Emory and Georgia Tech, its also Mayo, and Wisconsin, and Pittsburgh, and weve brought in speakers from all over. Its really grown and become a highly recommended event in the regenerative medicine community.

Trainees postdocs, grad students, and at least one undergraduate had a chance to present their work, also. First there was the rapid fire presentations (5 minutes) on Thursday afternoon, then a research poster competition that night, featuring 65 different projects on display.

The winning poster came from Daniel Hachim, a grad student at the University of Pittsburgh, whose project is entitled, Unveiling Macrophage Populations and Mechanisms Driving the Better Remodeling Outcomes Associated with Shifting Phenotype in the Host Response Against Biomaterials.

Cheryl San Emeterio, a Ph.D. student at Georgia Tech, has presented posters the last three years at this event, but this was her first rapid fire presentation.

I thought it was flattering and inspiring, to talk among so many distinguished scientists here, says San Emeterio, who does her research in the lab of Ed Botchwey, associate professor in the Wallace H. Coulter Department of Biomedical Engineering (a joint department of Emory and Georgia Tech).

Its great to get my work out there on this scale, and I hope that people are interested and want to discuss it further. And maybe we can form some sort of productive collaboration, adds San Emeterio, whose research is entitled, Age-dependent immune Dysregulation during Repair of Volumetric Muscle Injury.

Standing near her poster for most of the evening was Madeline Smerchansky, a Petit Undergraduate Scholar from Georgia Tech attending her first Hilton Head conference. She saw the opportunity as something of an investment.

This is practice for the future, says Smerchansky, a third-year student.

At least one researcher during the four-day workshop offered a glimpse into the future from a perspective that did not include biomolecular science or immunology. Aaron Levine offered his insights , but not the usual stuff based in biomolecular science or bioengineering. Aaron Levine, associate professor in the School of Public Policy at Georgia Tech and a Petit Institute researcher, delivered a presentation called, Regenerative Medicine in a Time of Policy Uncertainty.

We havent seen a lot of clear signals yet with how the policy environment is going to play out from the current presidential administration, says Levine, who focused his Friday morning talk on, among other things, potential policy drivers for regenerative medicine, such as the 21st Century Cures Act (will it be implemented by this administration, and if so, how much of it?), and the appointment of a commissioner for the Food and Drug Administration (FDA).

The future of the Cures Act may be largely dependent on who the next FDA commissioner is, noted to Arnie Caplan, of Case Western University, during Levines post-talk Q&A session.

Later that evening, it was Caplans turn to take center stage, with Chris Evans of the Mayo Clinic.

They were the main event, you might say. With a backdrop of Caplan and Evans as photo-enhanced boxers, the mood was light for their Friday night debate, entitled, MSCs are Not Stem Cells. Or, as Nerem put it, is an MSC a mesenchymal stem cells, a medical signaling cell, or a mediocre scientific concept.

By all accounts, they verbally fought to a draw. But who knows. Maybe there will be a rematch in 2018, when the Regenerative Medicine Workshop will return to Hilton Head (March 21-24).

CONTACT:

Jerry Grillo Communications Officer II Parker H. Petit Institute for Bioengineering and Bioscience

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Regenerative Medicine Workshop, Part 21 - Research Horizons