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Federal government renews contract for collecting and maintaining national stem cell transplantation database

Public release date: 1-Nov-2012 [ | E-mail | Share ]

Contact: Rachel Mosey rmosey@mcw.edu Medical College of Wisconsin

The Medical College of Wisconsin (MCW) Center for International Blood and Marrow Transplant Research (CIBMTR) successfully competed for, and was awarded, renewal of the Stem Cell Therapeutics Outcomes Database contract with the U.S. Health Resources and Services Administration (HRSA). The CIBMTR administers the database as a key component of the national hematopoietic cell transplantation program. Hematopoietic stem cells are the cells responsible for continual regeneration of circulating blood cells throughout life; they are not embryonic stem cells.

The HRSA first awarded the contract to CIBMTR in 2006 to develop and maintain the national Stem Cell Therapeutic Outcomes Database (SCTOD), which is a standardized outcomes registry of allogeneic (related and unrelated donor cells) marrow and cord blood transplants performed in the United States. Funding for the first year of this new contract is $3.8 million, with an additional four years of negotiable funding.

The outcomes registry of the CIBMTR currently contains the status of 330,000 transplant recipients, as well as critical information to continually evaluate the operations of the national transplant program. All U.S. transplant centers that perform allogeneic marrow and cord blood transplants are required to provide patient outcomes data to the registry.

"CIBMTR is privileged to continue to operate the Outcomes Database on behalf of the C.W. Bill Young Cell Transplantation Program," said J. Douglas Rizzo, M.D., M.S., professor of medicine at MCW, associate scientific director at CIBMTR and principal investigator of the SCTOD. "CIBMTR delivers value by using the Outcomes Database to provide clinicians, scientists, patients and policymakers the information they need to make the best possible clinical decisions. It is a beneficial platform to expand important research to advance the field, plan clinical trials, facilitate quality improvement and perform studies on behalf of policymakers. The major goal of the program is to make blood and marrow transplants available to all who need them, and to increase their safety and effectiveness."

Congress first enacted HRSA's C.W. Bill Young Cell Transplantation Program in 2005, which led to the creation of the Stem Cell Therapeutic Outcomes Database. Congress reauthorized the Program in 2010. It is named after U.S. Congressman C.W. Bill Young of Florida, who was instrumental in founding a national marrow donor registry that could provide potentially life-saving treatment for those diagnosed with leukemia and other blood diseases.

The Medical College's CIBMTR is a partnership formed through an affiliation of the Medical College's International Bone Marrow Transplant Registry and the National Marrow Donor Program (NMDP). Since 1972, the Center has collected outcomes data provided voluntarily by transplant centers worldwide on both allogeneic (related and unrelated donor cells) and autologous (patient's own cells) hematopoietic stem cell transplants, and has made these data available to investigators and physicians worldwide to perform research to advance the field. The CIBMTR has published nearly 800 peer-reviewed papers (more than 45 in the past year alone) and is conducting more than 250 observational studies. It also has helped to coordinate 28 national clinical trials in HCT, 18 of which have completed accrual.

In addition to the Stem Cell Therapeutic Outcomes Database, HRSA recently awarded other C.W. Bill Young Cell Transplantation Program contracts to the NMDP, in order to continue the Program's work as the Office of Patient Advocacy/Single Point of Access for transplant patients, the Bone Marrow Coordinating Center and the Cord Blood Coordinating Center.

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Federal government renews contract for collecting and maintaining national stem cell transplantation database

Stem cells could heal equine tendon injuries

ScienceDaily (Nov. 1, 2012) Tendon injuries affect athletic horses at all levels. Researchers from the University of Connecticut are studying the use of stem cells in treating equine tendon injuries. Their findings were published Oct. 16 in the Journal of Animal Science Papers in Press.

Tendon injuries in horses tend to worsen over time as damage to the tendon creates lesions. Currently, horse owners treat tendon injuries by resting the horse and then carefully exercising the horse to control the growth of scar tissue in the tendon. Unfortunately, this treatment does not always work.

"These injuries result in lameness, which requires substantial recovery time and carry a high risk of re-injury," write authors S.A. Reed and E.R. Leahy.

Stem cells injections are already common veterinary medicine, and scientists are curious how to make stem cell treatments more effective. In this paper, the authors looked at the use of three types of stem cells: bone marrow-derived mesenchymal stem cells, adipose-derived stem cells and umbilical cord blood-derived stem cells.

These types of cells have the potential to strengthen a tendon after injury. Implants of bone marrow-derived mesenchymal stem cells (BMSC) can increase collagen production and organized collagen fibers in the tendon. Adipose-derived stem cells can express certain proteins important in healing.

However, stem cells are not a miracle cure. Implantation can be tricky, and stem cells do not always decrease recovery time. Some BMSC transplantations have also led to the growth of unwanted bone in the tendon.

Umbilical cord blood-derived stem cells (UCB) may have the most potential for healing horse injuries in the future. These cells may be better able to grow into new types of cells and repair tendon damage. So far there have been no studies of UCB use in actual horse tendon injuries. But in vitro studies show that UCB could be capable of tendon regeneration.

The authors recommend future studies into implantation techniques and the role of stem cells in different parts of the tendon. With this knowledge, horse owners, veterinarians and animal scientists can help keep equine athletes healthy.

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Stem cells could heal equine tendon injuries

Service dog receives first stem-cell treatment at new clinic

By all preliminary accounts, the first stem-cell therapy treatment done on a canine in Nicholasville is a complete success.

The 8-year-old golden Labrador and service dog, Booster, had been showing signs of hip dysplasia and became the first to undergo the revolutionary new stem-cell therapy in the recently completed animal clinic of MediVet America located off U.S. 27 and Moore Drive.

Booster travels all over the world with owner Davis Hawn to teach others about the healing power of dogs, Hawn said.

As Booster got older, Hawn noticed the dogs hips were hurting more as Booster showed pain just trying to sit down and began to have difficulty jumping into the truck.

This prompted Hawn to look into methods of protecting and helping his best friend. He did not want Booster to suffer through the long and painful process of a hip replacement, and this is when he heard about the regenerative benefits of stem-cell therapy and the work MediVet was conducting.

It just so happened to work out that the pair would be in Cincinnati last week, coinciding with the opening of the new Nicholasville clinic at MediVet by Joseph G. Yocum, D.V.M., who specializes in large-animal vet research.

MediVet America is one of the leading developers of animal stem-cell regenerative therapy for pets suffering from osteoarthritis, hip dysplasia, ligament and cartilage injuries, and similar ailments.

MediVet had been in contact with Hawn and knew the story behind his relationship with the life-saving service dog.

The company then worked with Hawn and decided to conduct the inaugural stem-cell treatment completely free of charge as a way to celebrate the clinics opening while preserving Boosters quality of life.

Until about 2008, small animals suffering like Booster had only painkillers and anti-inflammatory medications to help with pain relief which are harmful to the liver and may offer only minor relief.

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Service dog receives first stem-cell treatment at new clinic

UR researchers find new uses for stem cell therapies in disease treatment

Courtesy of highlands.edu

The diagnosis of a neurological disease can represent what many patients see as a point of no return, but research published on Thursday, Oct. 25 by UR scientists on stem cell therapy points toward a potential for lessening the severity of the outcomes of these diagnoses.

The research, which was published in the journal Science, was conducted by UR researchers Steve Goldman, Maiken Nedergaard and Martha Windrem, addresses stem cells capable of transforming into the brains two main support cells, astrocytes and oligodendrocytes. The latter is lost in a family of neurological diseases classified as myelin disorders.

Myelin disorders include Multiple Sclerosis, Cerebral Palsy and Tay-Sachs disease, among others. These diseases are well known for being life-altering, so research with implications for dampening their effects will have an important impact on patients and their families once brought to the practical level.

This particular type of cell therapy would rely on programming stem cells to propagate glial progenitor cells. Progenitor cells then give rise to oligodendrocytes, which insulate neurons with a fatty substance called myelin. In total, this process ensures the speed and efficiency of neuronal communication. Without myelin, nerve communication throughout the body becomes weakened, which is the underlying pathology that causes the slowed cognitive processes and muscle dysfunction that are characteristic of myelin disorders.

Goldmans lab was instrumental in understanding the chemical signals necessary to not only turn stem cells into progenitor cells, but also to ensure that they specifically produce oligodendrocytes.

According to Goldman, the teams research focused on using stem cells to create glial progenitor cells purposely because they are less variable than other cells found in the central nervous system and thus present a relatively direct target.

This research on myelin replacement, although pointed toward a specific goal in the end, actually derives from research of something seemingly unrelated: song birds.

We worked primarily on stem cells of the brain that give rise to new neurons to try and understand how they progenerate regions of damaged brain, and thats work that started and still continues in song birds, Goldman said. Every time they learn a new song, their brains lay down a new bunch of neurons that control the song. Theres been a lot of effort over the years to understanding the biology of how birds sing, which then led to studies of brain progenitor cells, not only in birds, but in mammals, and eventually humans. Thats when we found out about brain progenitor cells that give rise to oligodendrocytes and astrocytes instead of neurons.

Goldman and his colleagues research has been taken to the brink of human clinical trials, which is now the final frontier for the practical application of this therapy.

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UR researchers find new uses for stem cell therapies in disease treatment

Autologous Stem Cell and Non-Stem Cell Based Therapies Market (2012-2017) (Neurodegenerative, cardiovascular, cancer …

NEW YORK, Nov. 1, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Autologous Stem Cell and Non-Stem Cell Based Therapies Market (2012-2017) (Neurodegenerative, cardiovascular, cancer & autoimmune, skin and infectious diseases)

http://www.reportlinker.com/p01022392/Autologous-Stem-Cell-and-Non-Stem-Cell-Based-Therapies-Market-2012-2017-Neurodegenerative-cardiovascular-cancer--autoimmune-skin-and-infectious-diseases.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

Autologous cell therapies are new therapeutic intervention where it introduces or uses cells or tissues from the individual, cultured, expanded and re-introduced at the site of the disease of the donor. They are widely promoted as next pillar or advancement in medical care.

Growth of the market is very rapid especially in regulatory approvals, applications areas and rapid improvements in efficacy of treatment; it has enormous advantages over allogenic stem cell therapies. Autologous transplants are relatively safe procedures, with less rates of complications and infections compared with allogenic transplants. In many instances, much of the procedure can be done on an outpatient basis. It helps in treating various dreadful diseases by transplanting their own body cells where it results in meager chances of transplant rejection.

We have also profiled leading players of this industry with their recent developments and other strategic industry activities. These include: Neostem (U.S.), Tengion (U.S.), Brainstorm Cell Therapeutics (U.S.), Dendreon Corporation (U.S.), Georgia Health Sciences University (U.S.), Regenexx (U.S.), Regeneus (Australia), Cytori Therapeutics (U.S.), Tigenix (Belgium).

Scope of the Report

This research report titled "Autologous Cell Therapy (2012-2017)" provides details about various ACT based treatments and their application areas. Every health regulatory bodies will be expecting companies and universities to develop therapy treatments, which are safer, affordable, robust, rapid, easy to use, effective and deliverable to the end user. ACT treatments for particular application areas it is safe, experiencing robust growth, minimal steps of procedure to follow and rapid in deriving the results. As for now the treatments prices are not affordable, but by the intrusion of government bodies, it will definitely experience a immense market growth.

The report gives a detailed analysis about state of the art of autologous cell therapies. It includes the current advances and applications of the technology and trends in terms of market size and growth of autologous cellular therapies in medical treatments globally. It also consists of funding details of the innovative therapy and recent activities in terms of mergers & acquisitions of the company, revenue forecasting. It includes latest therapy details and products which are available for licensing and approvals from various regulatory bodies. Using drivers, restraints and challenges it is forecasted for a period of five years i.e. 2012-2017. Opportunity strategy evaluation has been included which gives information for investors.

Autologous Cell Therapy technology is changing the medicinal treatments by introducing various new therapies. Its scope is vast and promising for the future despite challenges.

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market (2012-2017) (Neurodegenerative, cardiovascular, cancer ...

Sugar Land company ceases supplying stem cells

Under fire from the Food and Drug Administration, the Houston-area company that facilitated Gov. Rick Perry's controversial 2011 stem-cell treatment has stopped providing doctors with the cells patients banked at its facility for the procedure.

In a response to an FDA warning that it is acting illegally by marketing the unlicensed therapy, Celltex Therapeutics Corp. wrote the federal agency this week that it has ceased enrolling patients in the clinical trials the state requires of stem-cell providers. Celltex was the Houston area's primary sponsor of such for-profit trials.

"We're telling potential patients that we will still bank their stem cells and will enroll them in trials once new investigational drug applications have been submitted and reviewed by the FDA," said Amdrea Ferrenz, Celltex's executive vice president and legal counsel. "We hope that will be in a matter of months."

Ferrenz called the FDA warning letter, publicly posted Tuesday, "a disappointment" but said it actually just moves up Celltex's plan to move into agency-approved trials targeting specific disease conditions. The Sugar Land company had been operating for nearly 18 months facilitating adult stem-cell procedures with little regulation.

The Texas Medical Board in July began requiring that any stem-cell procedure be reviewed for patient safety by a board expert at such evaluations. The board used by Celltex, Texas Applied Biomedical Services, last month received an FDA warning letter of its own, informing it the agency will withhold approval of all its reviews because of problems with the review board's operations, such as members with conflicts of interest.

FDA warning letters are considered big deals in drug regulation, the federal agency's principal means of achieving compliance. They include language that failure to take corrective action can result in company seizure or shutdown.

It is unclear if the FDA letters to Celltex and the review board will have an effect on the new medical board rules, meant to regulate the experimental therapy in the absence of oversight from the FDA. A medical board spokeswoman said this week that the board could reopen the matter at its November meeting.

Leigh Turner, a University of Minnesota bioethicist who writes frequently about stem-cell tourism and in February complained to the FDA that Celltex is "a potential danger to patients" and not in compliance with federal law, said he thinks it's "highly unlikely" that Celltex could quickly meet FDA requirements for research trials. He said Celltex would need to make a dramatic reconfiguration considering all the deficiencies an FDA inspection found in April.

Those included numerous basic manufacturing problems, all reiterated in the warning letter. Ferrenz said Celltex is eager to meet with FDA officials to learn what they still want to know beyond the "tons of information" the company has already sent.

Celltex had argued stem-cell injections are like bone marrow transplants and not subject to the FDA's jurisdiction. But in its warning letter, the FDA said Celltex's processing "alters the original relevant characteristics" of the cells and hence doesn't meet its requirement that living cells only be "minimally manipulated." It categorized the stem cells stored and treated at Celltex as biologic drugs.

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Sugar Land company ceases supplying stem cells

Stem cell op may 'restore sperm'

1 November 2012 Last updated at 23:09 ET By James Gallagher Health and science reporter, BBC News

Boys left infertile by childhood cancer treatment may one day be able to produce healthy sperm by using stored stem cells, monkey research suggests.

Chemotherapy and radiotherapy can kill tumours and the cells which make sperm.

A study, published in the journal Cell Stem Cell, extracted sperm-producing stem cells before cancer treatment and later placed them back into the monkey.

Sperm which could fertilise an egg were produced, which experts labelled a "milestone" in research.

Most men who have cancer treatment which could affect their fertility can choose to freeze sperm before their treatment starts. This is not an option for patients who have not yet gone through puberty.

These are issues we still must work through, but this study does show us the concept is feasible

However, they do have the spermatogonial stem cells which would start to produce sperm in their teenage years.

The researchers at the University of Pittsburgh and the Magee-Womens Research Institute took samples of the stem cells from macaques and stored them in a freezer.

The monkeys were then given a chemotherapy drug.

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Stem cell op may 'restore sperm'