StemCell Therapy

The head of a stem cell company has responded to a warning letter issued by the U.S. Food and Drug Administration that cites several violations at the company that derives stem cells from adipose tissue or body fat.

Dr. Steven Victor of IntelliCell BioSciences said it would be moving to a new facility next month that it believes will address the current good manufacturing practice issues referred to in the warning letter It has also hired consultants with FDA-compliance experience that will help bring its new facilities in compliance with the FDA. Victor added that the company will address all of the FDAs observations on April 3.

The New York company received a warning letter dated March 13 that was published on the FDAs website yesterday. The letter said that the process that the company uses to produce stem cells from adipose tissue did not meet the FDAs definition of minimal manipulation for structural tissue such as adipose tissue.

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That provision section 1271.10 of the Code of Federal Regulations for Food and Drugs requires that the products, in this case, stem cells, are used for the person the cells are taken from, or a first or secondary relative, not combined with anything else other than water, a preservative, or sterilizing or storage products. It also permits these cells to be used for reproduction. Treatments that do not fall within this provision are classified as a drug.

Although there are numerous clinical trials using stem cells to treat cancer and rare diseases, critics say the FDAs intransigence on stem cell treatments using adult stem cells has produced unintended consequences. Private clinics in the U.S. and outside the country are using adult stem cells for cosmetic surgery and treating other maladies like back pain with no clinical trials to prove their efficacy and safety.

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CEO of stem cell company responds to FDA warning letter

As the basketball frenzy that accompanies March Madness draws to the fever pitch of the Final Four, it brings to mind that basketball is a high contact sport. A quick peek at the NBA injured list reveals a catalog of breaks and tears affecting tendons, ligaments and bones.

The pressure to improve performance and search for quick recoveries has led some celebrity athletes to seek out stem cell treatments overseas and in the U.S. Among NBA players to get stem cell treatments are Jason Kidd, Tracy McGrady, Amar Stoudemire, Allan Houston and Kenyon Martin, according to a Sports Illustrated article.

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Dragoo said in a phone interview that the publicity has actually had a negative impact on the development of clinically proven stem cell therapies for orthopedic medicine and how it is perceived.Because of this market pressure, private clinics have been offering stem cells treatments both here in the USA as well as around the world. Often these treatments have not been studied and are not regulated in any way. FDA regulations have also severely limited new clinical trials in stem cell therapy in the USA.

The ethical debate of using embryonic stem cells taken from fetuses has been sidestepped to some extent by the viability of adult stem cells for stem cell therapy. Although the U.S. Food and Drug Administration permits cells being extracted from individuals, transformed into stem cells and re-inserted back into the same person, it requires that the conversion involve no more than water, preservatives and storage products. Anything more than that, the FDA policy goes, would be classified as a drug therapy and need to go through the proper application protocol.

But a much-awaited decision by the U.S. District Court in Washington, DC expected in May that may resolve a four-year old battle between the FDA and Regenerative Science in Colorado could represent a sea change in how autologous adult stem cell treatments are regulated. The FDA is seeking to prevent the company from providing autologous adult stem cell treatment for musculoskeletal and spinal injuries. If the FDA were to lose, anyone with a medical license could develop autologous stem cells and inject them back into patients, without any regulatory oversight, according to a Cell Press article.

Although stem cells there are the focus of numerous clinical trials, they are mainly for cancer and rare diseases, with most being conducted outside the United States. While there have been some developments for sports medicine applications produced by research from academic institutions, there have been no clinical trials for stem cell treatments in sports medicine in the United States because of the U.S. Food and Drug Administrations reservations about using adult stem cells. Despite the laxer regulations in Japan, China and Europe, its not in the financial interest of companies there to spend the money to do clinical trials if they dont have to.

Among the most interesting applications for orthopedic medicine are the restoration of articular cartilage and patching defects in joint cartilage, with the hope of resurfacing arthritic joints in the future, Dragoo said. Stanford is preparing to initiate its own clinical trial next year looking at inducible stem cells.

This technique takes adult cells and make them young again by inserting four genes which makes the cells immature and allows them to be directed into different types of tissues, Dragoo said.

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Basketball’s influence on stem cell treatments in sports medicine

28-03-2012 10:17 Dr Joshua Hare is Professor of Medicine and Director of the Interdisciplinary Stem Cell Institute at the University of Miami. The interview was conducted on 25 March 2012 at the American College of Cardiology's (ACC's) 61st Annual Scientific Session & Expo in Chicago. See more ACC.12 Coverage: http://www.getinsidehealth.com

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Stem cell therapy for the repair of myocardium in heart failure patients - Video

Public release date: 28-Mar-2012 [ | E-mail | Share ]

Contact: Evan Lerner elerner@upenn.edu 215-573-6604 University of Pennsylvania

PHILADELPHIA Treatments for childhood cancers are increasingly successful with cure rates approaching 80%, but success often comes with a downside for the surviving men: the cancer treatments they received as boys can leave them sterile as adults. Now, a research team led by Ralph Brinster of the University of Pennsylvania School of Veterinary Medicine has completed a 14-year experiment that gives hope for a technique that could restore their fertility.

Brinster is the Richard King Mellon Professor of Reproductive Physiology at Penn Vet and was recently awarded the National Medal of Science for his lifetime of research on the genetics of the mammalian germline, the cells that give rise to sperm and eggs.

In his most recent research, Brinster collaborated with fellow members of the Department of Animal Biology at Penn Vet, with members of the Department of Cell and Developmental Biology at Penn's Perelman School of Medicine and with the Penn Bioinformatics Core.

Their study was published in the journal Human Reproduction.

For males, fertility begins with spermatogonial stem cells, which are present at birth, embedded in the basement membrane of the testes' seminiferous tubules. As a boy approaches puberty, these cells begin to make daughter cells that eventually become sperm. While they normally continue this process throughout a post-pubescent man's life, factors like radiation and chemotherapy drugs can destroy them, rendering him sterile.

About 1 in 3 boys surviving childhood cancer will be in danger of having severely decreased fertility as an adult; as many as 1 in 5,000 men of reproductive age currently suffer this serious quality-of-life problem as a result. Adult men who undergo cancer treatment that might damage their fertility can preemptively freeze their sperm, an option not available to pre-pubescent boys. But if a sample of a boy's spermatogonial stem cells could be extracted and preserved before cancer treatment and re-implanted after the boy reached adulthood, this fertility problem could be circumvented.

"There are a number of places, including at the Children's Hospital of Philadelphia," Brinster said, "that are already freezing cells for patients to use later, with the expectation that the necessary culture system and implantation techniques will be developed. A logical question for patients to ask is, How do we know that, after 10 years or more of being stored, these cells are any good? That's what our study addresses."

The techniques for extracting these cells and re-implanting them have been developed, so a critical question for researchers was whether spermatogonial stem cells could survive the decade-plus period they might need to remain frozen.

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Penn research points to new way of preserving fertility for boys undergoing cancer treatment

ROCKVILLE, Md., March 28, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE Amex: CUR) announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, STEM CELLS, on March 13th. "Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients" (http://www.ncbi.nlm.nih.gov/pubmed/22415942.1) reports that one patient has shown improvement in his clinical status, even though researchers caution that the study was not designed to show efficacy. Additionally, there was no evidence of accelerated disease progression due to the intervention in any of the 12 patients, who were followed from 6-18 months after they were transplanted with the cells. All of the patients, who received transplants in the lumbar (lower back) region, tolerated the treatment without any long-term complications related to either the surgery or the cells.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

The 12 patients, part of the ongoing Phase I trial to evaluate the safety of Neuralstem's stem cells and transplantation procedure in patients with ALS, were the first in the world to receive intraspinal stem cell injections. Results from these patients were also were reported at the American Academy of Neurology Annual Meeting last September.

Based on a positive safety assessment, the trial has now been approved by the FDA to progress to transplanting ALS patients in the cervical (upper back) region of the spine, where the goal is to protect the motor neurons which affect respiratory function, and possibly prolong life. The fourteenth patient was transplanted earlier this month. All patients were treated at Emory University Hospital in Atlanta, Georgia.

"For these first 12 patients, we have met the objective of the Phase I trial, demonstrating safety for both the procedure of intraspinal injection and the presence of the neural stem cells in the spinal cords of ALS patients," said Jonathan Glass, MD, lead author of the publication. "We are encouraged by these results and have now advanced our trial to injections into the cervical spinal cord, targeting the motor neurons that control respiratory function." Dr. Glass is Professor of Neurology and Pathology at Emory University School of Medicine, as well as the Director of the Emory ALS Center.

"This important peer-reviewed publication reinforces our belief that we have demonstrated a safe, reproducible and robust route of administration into the spine for these spinal cord neural stem cells," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "The publication covers data up to 18 months out from the original surgery. However, we must be cautious in interpreting this data, as this trial was neither designed nor statistically powered to study efficacy." Dr. Feldman is senior author on the study, principal investigator (PI) of the ALS trial and serves as a consultant to Neuralstem as part of her University of Michigan activities.

"As this article points out, our experience in the lumbar spinal cord has been overwhelmingly positive," commented Karl Johe, PhD, study author and Neuralstem Chairman and Chief Scientific Officer. "We have already transplanted two patients in the cervical spinal cord, where we believe we can affect patients' lives the most by improving their breathing. We are in active discussions with the FDA to increase the number of cells and the number of injections as well."

"We wish to thank the teams at Michigan and Emory for the tireless efforts required to refine this breakthrough method of administration of our neural stem cells. We'd also like to thank the patients and families involved in the trial," said Richard Garr, Neuralstem CEO and President. "The progress we have made to date is both substantial, and a true team effort."

About the Study

Safety results were reported on the first 12 patients in an ongoing Phase I study to evaluate the safety of Neuralstem's spinal cord stem cells (HSSC's), as well as the transplantation technique, in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease).

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Neuralstem ALS Stem Cell Trial Interim Results Reported in the Journal, STEM CELLS

Public release date: 28-Mar-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY -- A novel method for printing human cells onto surfaces in defined patterns can help advance research on tissue engineering and regeneration, as described in an article in Tissue Engineering, Part C, Methods, a peer-reviewed journal from Mary Ann Liebert, Inc (http://www.liebertpub.com). The article is available free online at the Tissue Engineering website (http://www.liebertpub.com/ten).

"Cell printing is one of the breakthrough technologies that will make the application of stem cells for tissue engineering feasible," says John Jansen, DDS, PhD, Methods Co-Editor-in-Chief and Professor and Chairman, Department of Biomaterials, Radboud University Nijmegen Medical Center, The Netherlands.

Yu Fang and colleagues, University of Michigan, Ann Arbor, combined two microscale techniques to dispense and position cells in a variety of patterns. They then demonstrated the ability to use these 3-dimensional cell systems to monitor cell signaling events known to have a role in the growth, proliferation, and metastasis of cancer cells. The authors describe the use of sound waves to deliver microdroplets of cells and polymer-based phase separation to control cell placement in the article "Rapid Generation of Multiplexed Cell Co-Cultures Using Acoustic Droplet Ejection Followed by Aqueous Two-phase Exclusion Patterning." (http://online.liebertpub.com/doi/abs/10.1089/ten.TEC.2011.0709)

###

About the Journal

Tissue Engineering (http://www.liebertpub.com/ten) is an authoritative peer-reviewed journal published monthly in print and online in three parts: Part A--the flagship journal; Part BReviews; and Part CMethods. Led by Co-Editors-In-Chief Antonios Mikos, PhD, Louis Calder Professor at Rice University, Houston, TX, and Peter C. Johnson, MD, Vice President, Research and Development, Avery Dennison Medical Solutions of Chicago, IL and President and CEO, Scintellix, LLC, Raleigh, NC, the Journal brings together scientific and medical experts in the fields of biomedical engineering, material science, molecular and cellular biology, and genetic engineering. Tissue Engineering is the official journal of the Tissue Engineering & Regenerative Medicine International Society (TERMIS). Complete tables of content and a sample issue may be viewed online at the Tissue Engineering website (http://www.liebertpub.com/ten).

About the Company

Mary Ann Liebert, Inc.(http://www.liebertpub.com), is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Stem Cells and Development, Human Gene Therapy and HGT Methods, and Biopreservation and Biobanking. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available at Mary Ann Liebert Inc. (http://www.liebertpub.com).

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Innovative cell printing technologies hold promise for tissue engineering R&D

27-03-2012 03:04 Fat Stem Cell Therapy - Animation shows our basic procedure for stem cell isolation and activation in Anti-Agng and nuerological disorders.

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Fat Stem Cell Therapy - Anti Aging - Video

NEW YORK, NY--(Marketwire -03/28/12)- Biotechnology stocks have been on an impressive run this year as favorable legislation out of Washington is allowing biotech companies of all sizes to more easily navigate regulations. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on Advanced Cell Technology Inc. (OTC.BB: ACTC.OB - News) and PharmAthene Inc. (AMEX: PIP - News). Access to the full company reports can be found at:

http://www.fivestarequities.com/ACTC http://www.fivestarequities.com/PIP

The Biotechnology Industry Organization (BIO) recently applauded the House Energy and Commerce Committee's passage of the Medicare Decisions Accountability Act, H.R. 452, which would repeal the Independent Payment Advisory Board (IPAB) established in the health care reform law. BIO also issued a press release applauding the Senate on the passage of H.R. 3606, the Jumpstart Our Business Startups (JOBS) Act. The JOBS Act creates an "on-ramp" to the public market for emerging growth companies, allowing them five years to focus on conducting critical research that can lead to cures for debilitating diseases before having to divert funds to costly regulations, BIO reports.

Five Star Equities releases regular market updates on the biotechnology industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at http://www.fivestarequities.com and get exclusive access to our numerous stock reports and industry newsletters.

Advanced Cell Technology, Inc., a biotechnology company, focuses on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. Earlier this month the company filed with the Securities and Exchange Commission a proxy statement containing a shareholder proposal for a reverse split of its common stock. "This reverse stock split, which should better align the company's capital structure with its stage of development, and an accompanying Nasdaq listing application, will represent a significant step toward creating long-term shareholder value and building ACT into a world-class player in the regenerative medicine space," said Gary Rabin, chairman and CEO of ACT.

PharmAthene, Inc., a biodefense company, engages in the development and commercialization of medical countermeasures against biological and chemical weapons in the United States. For the year ended December 31, 2011, PharmAthene recognized revenue of $24.3 million, compared to $21.0 million in 2010.

Five Star Equities provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.fivestarequities.com/disclaimer

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Advanced Cell Technology and PharmAthene Poised to Benefit From Positive Legislation

NEW YORK, NY--(Marketwire -03/28/12)- Biotechnology stocks have been on an impressive run this year as favorable legislation out of Washington is allowing biotech companies of all sizes to more easily navigate regulations. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on Advanced Cell Technology Inc. (OTC.BB: ACTC.OB - News) and PharmAthene Inc. (AMEX: PIP - News). Access to the full company reports can be found at:

http://www.fivestarequities.com/ACTC http://www.fivestarequities.com/PIP

The Biotechnology Industry Organization (BIO) recently applauded the House Energy and Commerce Committee's passage of the Medicare Decisions Accountability Act, H.R. 452, which would repeal the Independent Payment Advisory Board (IPAB) established in the health care reform law. BIO also issued a press release applauding the Senate on the passage of H.R. 3606, the Jumpstart Our Business Startups (JOBS) Act. The JOBS Act creates an "on-ramp" to the public market for emerging growth companies, allowing them five years to focus on conducting critical research that can lead to cures for debilitating diseases before having to divert funds to costly regulations, BIO reports.

Five Star Equities releases regular market updates on the biotechnology industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at http://www.fivestarequities.com and get exclusive access to our numerous stock reports and industry newsletters.

Advanced Cell Technology, Inc., a biotechnology company, focuses on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. Earlier this month the company filed with the Securities and Exchange Commission a proxy statement containing a shareholder proposal for a reverse split of its common stock. "This reverse stock split, which should better align the company's capital structure with its stage of development, and an accompanying Nasdaq listing application, will represent a significant step toward creating long-term shareholder value and building ACT into a world-class player in the regenerative medicine space," said Gary Rabin, chairman and CEO of ACT.

PharmAthene, Inc., a biodefense company, engages in the development and commercialization of medical countermeasures against biological and chemical weapons in the United States. For the year ended December 31, 2011, PharmAthene recognized revenue of $24.3 million, compared to $21.0 million in 2010.

Five Star Equities provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.fivestarequities.com/disclaimer

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Advanced Cell Technology and PharmAthene Poised to Benefit From Positive Legislation

MIDDLETOWN

Wesleyan University researchers have reported some encouraging results about the potential for stem cells to treat a particularly debilitating form of epilepsy.

The research is the result of the collaboration of three labs at Wesleyan and focuses on temporal lobe epilepsy, which can be particularly difficult to treat, because many people who suffer from it don't respond to anti-seizure medications.

The condition usually begins with some kind of damage to the part of the brain known as the hippocampus, which then leads to the death of a particular neuron, the inhibitory interneuron.

"We started thinking about collaborating together to see if embryonic stem cells could be redirected to become the kinds of neurons that were dying," said Laura Grabel, professor of biology.

The first phase of the ongoing research resulted in a study published earlier this year in the Journal of Neuroscience.

Grabel and Janice Naegele, a developmental neurobiologist, worked together to develop a method of implanting embryonic stem cells of mice into the brains of mice. The mice were given a chemical to induce temporal lobe epilepsy.

"For the first time we could analyze the functions of these transplanted cells in the mice with the disease," Naegele said. "Are they responsible for preventing these seizures?"

To that end, the project was then turned over to Gloster Aaron, an assistant professor of neuroscience and behavior, who examined slices of the mice's brains under a microscope. The brain samples, kept in solution, can stay alive for eight to 12 hours. The results were promising.

"We found that these cells, derived from embryonic stem cells, could become functioning neurons in the brain," Grabel said. "Not only did they look like inhibitory interneurons, they behaved like them."

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Wesleyan Research Suggests Stem Cells Show Promise Treating Epilepsy

ScienceDaily (Mar. 27, 2012) A team of researchers led by scientists at Weill Cornell Medical College has designed what appears to be a powerful gene therapy strategy that can treat both beta-thalassemia disease and sickle cell anemia. They have also developed a test to predict patient response before treatment.

This study's findings, published in PLoS ONE, represents a new approach to treating these related, and serious, red blood cells disorders, say the investigators.

"This gene therapy technique has the potential to cure many patients, especially if we prescreen them to predict their response using just a few of their cells in a test tube," says the study's lead investigator, Dr. Stefano Rivella, Ph.D., an associate professor of genetic medicine at Weill Cornell Medical College. He led a team of 17 researchers in three countries.

Dr. Rivella says this is the first time investigators have been able to correlate the outcome of transferring a healthy beta-globin gene into diseased cells with increased production of normal hemoglobin -- which has long been a barrier to effective treatment of these disease.

So far, only one patient in France has been treated with gene therapy for beta thalassemia, and Dr. Rivella and his colleagues believe the new treatment they developed will be a significant improvement. No known patient has received gene therapy yet to treat sickle cell anemia.

A Fresh Approach to Gene Therapy

Beta-thalassemia is an inherited disease caused by defects in the beta-globin gene. This gene produces an essential part of the hemoglobin protein, which, in the form of red blood cells, carries life-sustaining oxygen throughout the body.

The new gene transfer technique developed by Dr. Rivella and his colleagues ensures that the beta-globin gene that is delivered will be active, and that it will also provide more curative beta-globin protein. "Since the defect in thalassemia is lack of production of beta-globin protein in red blood cells, this is very important," Dr. Rivella says.

The researchers achieved this advance by hooking an "ankyrin insulator" to the beta-globin gene that is carried by a lentivirus vector. During the gene transfer, this vector would be inserted into bone marrow stem cells taken from patients, and then delivered back via a bone marrow transplant. The stem cells would then produce healthy beta-globin protein and hemoglobin.

This ankyrin insulator achieves two goals. First, it protects delivery of the normal beta-globin gene. "In many gene therapy applications, a curative gene is introduced into the cells of patients in an indiscriminate fashion," Dr. Rivella explains. "The gene lands randomly in the genome of the patient, but where it lands is very important because not all regions of the genome are the same." For example, some therapeutic genes may land in an area of the genome that is normally silenced -- meaning the genes in this area are not expressed. "The role of ankyrin insulator is to create an active area in the genome where the new gene can work efficiently no matter where it lands," Dr. Rivella says. He adds that the small insulator used in his vector should eliminate the kind of side effects seen in the French patient treated with beta-thalassemia gene therapy.

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New gene therapy approach developed for red blood cell disorders

A controversial chemical called Bisphenol A (BPA), which is used to harden plastics, is contributing to the global obesity epidemic, according to new research.

The claims by biologist Frederick vom Saal come as the Food and Drug Administration is expected to rule this week -- after four years of study -- on whether to ban the plastic additive from use in food packaging.

Vom Saal told The Daily he will soon release a new study showing that mothers who expose their fetuses to BPA run the risk of having obese children.

"During the development of the fetus, BPA exposure alters the development of stem cells," vom Saal, a professor at the University of Missouri, said. "Think of it as tripping a switch in the DNA. BPA turns out to be a major factor in the number of fat cells that a person will have later in life."

BPA first came to public consciousness in 2007 when concerns were raised that it was leaching from reusable water bottles, leading to most companies reformulating their containers. But the organic compound is still so ubiquitous that it has been found in the urine of 93 percent of Americans over age six. It is used to line metal food and beverage cans, and is found in dental sealants, household appliances and sports equipment.

Critics label BPA an "endocrine disruptor" that acts like synthetic estrogen and link it to a wide range of ailments, including cancer. But its scientific defenders -- as well as regulatory agencies in the United States, Australia, the European Union, Japan, and New Zealand -- say there is no evidence that the minuscule exposure that consumers receive poses a health risk.

Vom Saal said his study shows that even trace amounts of the chemical are enough to disrupt a developing child's genetic structure and lead to metabolic disorders.

His findings are just the latest new evidence that BPA may be playing a role in the global obesity epidemic. Another study released in February by a Spanish research team showed that even small amounts of BPA cause human adult islet cells to produce more fat in the body.

After long declaring that BPA was safe in low doses, the FDA amended its position on the chemical in 2010, stating that ongoing research showed that there was cause for "some concern" for its effects on fetuses and children. In response to a court order, the FDA is now reviewing whether BPA should be removed from food containers, and has agreed to make a decision by Saturday.

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Chemical in bottles and cans is fueling obesity, says scientist

ScienceDaily (Mar. 26, 2012) A breakthrough using cutting-edge stem cell research could speed up the discovery of new treatments for motor neuron disease (MND).

The international research team has created motor neurons using skin cells from a patient with an inherited form of MND.

Role of protein

Using patient stem cells to model MND in a dish offers untold possibilities for how we study the cause of this terrible disease as well as accelerating drug discovery by providing a cost-effective way to test many thousands of potential treatments said Professor Siddharthan Chandran, Director of the University's Euan MacDonald Centre for MND Research.

The study discovered that abnormalities of a protein called TDP-43, implicated in more than 90 per cent of cases of MND, resulted in the death of motor neuron cells.

This is the first time that scientists have been able to see the direct effect of abnormal TDP-43 on human motor neurons.

The study, led by the University of Edinburgh's Euan MacDonald Centre for Motor Neuron Disease Research, was carried out in partnership with King's College London, Columbia University, New York and the University of San Francisco.

Motor neuron disease

MND is a devastating, untreatable and ultimately fatal condition that results from progressive loss of the motor nerves -- motor neurons -- that control movement, speech and breathing.

The study, funded by the MND Association, is published in the journal Proceedings of the National Academy of Sciences.

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Stem cell study aids quest for motor neuron disease therapies

HYDERABAD: Lack of legislation and awareness coupled with quality and ethical Issues has been deterrent to the growth of stem cell therapy sector in India, where the bio-tech market is expected to achieve a market size of $ 8 billion by 2015, according to a report by the Yes bank.

Special provisions such as 10-year tax benefits, duty exemptions, fast tracking the approval process by giving it a status of orphan drug (as done in the US) are some measures which could be very helpful to become leaders in this sector, the report 'Stem Cells--an emerging Bio-sector' suggested.

"The legislation for this sector still is at the draft stage. A regulatory framework governing the sector, instead of the guidelines existing at present is essential for the proper growth of stem cell research and applications in India. There are also no guidelines regarding pricing which results in certain unproven injections being sold for around Rs 80,000," the report said.

Several companies are taking advantage of the lack of laws governing the stem cell segment and advertise their therapies and clinical trials as ICMR approved.

However, given the multi-tiered system of registration and approvals recommended in the ICMR's guidelines, some of these are based on fraudulent or exaggerated claims. Further, there are also ethical worries on the side-effects of such treatment, it further said.

In India, there are very few players in the stem cell sector and these are all in very nascent stages and industry consolidation with global players entering into the market through mergers and acquisition route could propel industry growth, it opined.

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Stem cell segment in India to touch $8 billion mark by 2015: Report

COLUMBIA, SC (WIS) - A few weeks ago, we told you the story of Maggie, the 13-year-old Boykin Spaniel who was suffering from arthritis.

Maggie is enjoying life once again thanks to a new type of surgery. The dog received stem cell therapy surgery six weeks ago.

Doctors were able to use adult stem cells from Maggie's blood and fat samples to collect repair cells. They then took the cells and repaired the dog's arthritic spine.

Maggie's owner, Beth Phibbs, says she could tell the dog had been in pain.

"You could tell she didn't feel well, but yet now she is like she's 5 and she's 13. She just runs out and she plays. I think she knows. She can feel the difference," Phibbs said.

The surgery costs about $2,000, but Medi-vet America says this costs about half as much as the older treatments.

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Stem cell therapy for 13-year-old dog helps with its arthritis

LOS ANGELES--(BUSINESS WIRE)--

ImmunoCellular Therapeutics, Ltd. (ImmunoCellular or the Company) (OTCBB: IMUC.OB - News), a biotechnology company focused on the development of novel immune-based cancer therapies, announced today that the Company will deliver a presentation on the identification and characterization of immunogenic epitopes from CD133 and their potential for use to immunologically target cancer stem cells (CSCs) at the Annual Meeting of the American Association for Cancer Research, which will be held from March 31 to April 4, 2012 at McCormick Place in Chicago, Illinois.

CD133 is a marker that identifies CSCs on many solid tumors and its expression has been correlated with shortened survival. Potential Cytotoxic T Lymphocytes (CTL) epitopes were identified by computer algorithms to predict binding to HLA-A2 tissue type on white blood cells. Studies with human cells in vitro demonstrated immunogenicity of two lead peptides and in vivo studies in mice confirmed the safety and immunogenicity of these peptides as a potential vaccine to target CD133 CSCs. The Company plans to incorporate these peptides into its second product, ICT-121, for recurrent glioblastoma as the initial indication, followed by additional solid tumors.

To evaluate the potential for autoimmunity, mouse homolog peptides of the lead epitopes that were shown to have high affinity binding to human HLA-A2 were used to immunize HLA-A2 transgenic mice. Mice were immunized 3 times at 3 week intervals and spleens were harvested and stimulated in vitro for one week with peptide pulsed antigen presentation cells. Interferon Gamma assays showed immune responses to the two lead peptides in 35% and 40% of mice. Organs, including heart, lung, liver, kidney, stomach, intestine, brain, bone marrow, gonads, and eyes from mice with immune responses were found to be negative for lymphocytic infiltrations supporting a lack of autoimmunity related to the immune response to these peptides. Together these studies support the safety and immunogenicity of these peptides as a potential vaccine to target CD133 cancer stem cells.

The Company will deliver its presentation titled Identification and characterization of immunogenic epitopes from CD133 and their potential for use to immunologically target cancer stem cells on Sunday, April 1, 2012, from 1:00 pm 5:00 pm CST in McCormick Place West (Hall F), Poster Section 19.

About ImmunoCellular Therapeutics, Ltd.

ImmunoCellular Therapeutics is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more aboutIMUC, please visitwww.imuc.com.

Forward-Looking Statements

This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the need for substantial additional capital to fund development of ICT-121 through to commercialization; the risk that safety and efficacy results for ICT-121 will not be confirmed in the human clinical trials; the risk that the FDA may impose additional testing requirements before proceeding to the clinical trials; the risks associated with adhering to projected preclinical or clinical timelines and the uncertainties of outcomes of development work for product candidates; and the risk of obtaining patent coverage for the ICT-121 vaccine or that any patents covering this vaccine will provide commercially significant protection for this product candidate. Additional risks and uncertainties are described in IMUC's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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ImmunoCellular Therapeutics to Present on Cancer Stem Cell Targeting at the AACR Annual Meeting

Blocking "don't destroy me" signals that normally sit on the surface of tumor cells and render them resistant to immune-cell attack slows the growth of a broad range of human cancers when they're implanted in mice, researchers have found.

The approach, reported by immunologists at the Stanford University School of Medicine, was effective against ovarian, breast, colon, bladder, liver, prostate and brain cancer cells. If the work can be repeated in people, the approach may someday help doctors marshal defender cells in patients' own bodies to fight cancers, the researchers said.

Key to the work is a cell protein called CD47, which is already being investigated in the treatment of leukemia.

CD47 sits on cell membranes and communicates with various immune cells, including macrophages, which gobble up foreign invaders in the body. It plays an important role in the normal life cycle of healthy red blood cells, telling macrophages to leave the cells alone.

In the study, the scientists injected the animals with antibodies that bind to CD47 and block out its protective signal.

"If we can block this signal, we can get the immune system to eat [the cancer cells] up," said Stephen Willingham, a postdoctoral researcher in the laboratory of immunologist Dr. Irving Weissman at Stanford and first author of a paper about the work.

The Stanford team examined cancer cells removed from patients with a variety of types of solid tumors. They found that CD47 studded the membranes of almost all of the cancer cells in their sample, suggesting that it is a molecule common to all cancers.

Placing the cells in lab dishes, the team administered an antibody: a protein that binds to CD47 and blocks it from warding off immune system cells. Macrophages ate the cells.

The researchers then implanted human tumor cells in mice for further study. They allowed the cancers to grow, and administered the antibody against CD47.

Antibody treatment inhibited the growth of almost all of the solid tumors and was able to wipe out some smaller cancers altogether, according to the report, which was published Monday in the journal Proceedings of the National Academy of Sciences.

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Cancer research targets a key cell protein

26-03-2012 10:10

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Top Questions About Liposuction - Fat Grafting and Stem Cells - Video

March 27, 2012

According to a new study, using a patients own bone marrow may help repair damaged areas of the heart caused by heart failure.

Researchers found that left ventricular ejection fraction increased by 2.7 percent in patients who received stem cell therapy.

The study, which was presented at the American College of Cardiologys 61st Annual Scientific Session, revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow.

This is the kind of information we need in order to move forward with the clinical use of stem cell therapy, Emerson Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute and the studys lead investigator, said at the event.

The study included 92 patients who were randomly selected to receive stem cell treatment or placebo. The patients all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure.

Doctors placed a catheter in the hearts left ventricle to inject 3 ccs, or 100 million stem cells, into an average of 15 sites of the stem cell patients hearts.

The doctors used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

With this mapping procedure, we have a roadmap to the heart muscle, said Dr. Perin. Were very careful about where we inject the cells; electromechanical mapping allows us to target the cell injections to viable areas of the heart.

The trial was designed to determine whether left ventricular end systolic volume and myocardial oxygen consumption improved in patients who received stem cell treatment.

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Cell Therapy Improves Damaged Heart In Study

March 27, 2012

According to a new study, using a patients own bone marrow may help repair damaged areas of the heart caused by heart failure.

Researchers found that left ventricular ejection fraction increased by 2.7 percent in patients who received stem cell therapy.

The study, which was presented at the American College of Cardiologys 61st Annual Scientific Session, revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow.

This is the kind of information we need in order to move forward with the clinical use of stem cell therapy, Emerson Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute and the studys lead investigator, said at the event.

The study included 92 patients who were randomly selected to receive stem cell treatment or placebo. The patients all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure.

Doctors placed a catheter in the hearts left ventricle to inject 3 ccs, or 100 million stem cells, into an average of 15 sites of the stem cell patients hearts.

The doctors used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

With this mapping procedure, we have a roadmap to the heart muscle, said Dr. Perin. Were very careful about where we inject the cells; electromechanical mapping allows us to target the cell injections to viable areas of the heart.

The trial was designed to determine whether left ventricular end systolic volume and myocardial oxygen consumption improved in patients who received stem cell treatment.

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Cell Therapy Improves Damaged Heart In Study