Adult Stem Cell Research Blossoming, (continued)

Sally Robbins

Department of Defense Creates AFIRM

Research is well underway among participating institutions since the U.S. Department of Defense announced in April 2008 the creation of a new $250 million institution focused on research called the Armed Forces Institute of
Regenerative Medicine (AFIRM). The virtual organization is a multi-institutional, interdisciplinary network working to develop advanced treatment options over the next five years for severely wounded service men
and women. AFIRM is managed and funded through the U.S. Army Medical Research and Materiel Command (USAMRMC), with additional funding from the U.S. Navy, U.S. Air Force, the National Institutes of Health, the Veterans
Administration and local public and private matching funding.

AFIRM has been designed to speed the delivery of regenerative medicine therapies to treat the most critically injured service members from around the world, but in particular those coming from theaters of operation in Iraq
and Afghanistan. There are five major programs: Limb Repair, Craniofacial Repair, Burn Repair, Scarless Wound Repair and Compartment Syndrome Repair.

AFIRM is made up of two civilian research consortia working with the U.S. Army Institute for Surgical Research (USAISR) in Fort Sam, Houston, Texas.

One consortium is lead by Rutgers, The State University of New Jersey, and the Cleveland Clinic and the other is led by Wake Forest University Institute for Regenerative Medicine and The McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Each of these civilian consortia is itself a multi-institutional network. There are a total of 28 civilian institutions involved.

"Our researchers are continuing to pursue promising avenues, such as tissue regeneration of fingertips," said AFIRM Investigator William Wagner, Ph.D., Deputy Director of the McGowan Institute for Regenerative Medicine. "We are also testing in animal models materials that could replace damaged abdominal wall muscles, and we might soon embark on a novel strategy that uses muscle-derived stem cells to heal severely injured tissue."
(http://www.mirm.pitt.edu)

Dozens of commercial interests are expressing a willingness to work with the AFIRM consortia as commercialization partners. The medical device industry has taken a keen interest in speeding these important new therapies to market, not just for injured service members, but for civilian patients as well. AFIRM believes this participation ultimately will lead to better healthcare options for all Americans.

All of the research now being funded will use adult-derived stem cells taken from the patient or from another consenting adult. AFIRM has stated adult stem cells and progenitor cells are an integral part of normal wound healing and the formation of all new tissues. Many of the strategies being developed by AFIRM seek to improve wound healing and tissue repair by increasing the number or improving the function of adult stem cells. A patient’s own cells, or in some cases, cells from another adult, are used in conjunction with special drugs called bioactive factors, or with advanced biomaterials that serve as scaffold for growth of new tissues. “The vision of the future is that before soldiers go off on operations they will have their own stem cells harvested through liposuction and stored for use if they get wounded. That way while a casualty is being stabilized overseas, we will be in the U.S. growing them muscle, skin or bone ready for surgery,” Sgt. Glen Rossman of USAISR told Soldier magazine (March 2009 issue).

Project Director Col. Bob Vandre also commented: “AFIRM’s research is very exciting news and should be very reassuring to soldiers. Some day we will be able to fix a lot of things. We currently have 12 clinical trials ready
to roll and that is a sign that AFIRM has arrived and is very much for real.”

Big Pharma Enter Arena

In what represents a major shift in the field, Pfizer announced in November 2008 it would spend $100 million over five years to develop therapies from stem cells with the launch of Pfizer Regenerative Medicine
(http://www.pfizer-regenerativemedicine.com), a global unit based in Cambridge, MA and Cambridge, the UK.

The U.S. unit is focusing on using stem cells to develop therapies for cardiac disorders and cancer through in-house research and a vast array of alliances and collaborations, and will grow its team to 20 scientists. The U.K. arm will grow to 60 scientists over the next two years with a focus predominately on age-related and degenerative disorders with particular interest in common cellular mechanisms and disorders of the central and peripheral nervous system.

Pfizer Regenerative Medicine is operating as an independent research unit and is basing its stem cell research and drug discovery efforts on a full set of drug discovery capabilities.

Earlier in 2008, Pfizer invested $3 million with La Jolla, CA-based startup EyeCyte, Inc. (http://www.eyecyte.com) to develop treatments for diabetes-induced retinal damage, a leading cause of blindness, using patient blood and bone marrow-derived progenitor cells.

In addition, Epistem Plc (http://www.epistem.co.uk), the UK-based biotechnology and research services company, announced in March 2009 that it had signed a research and development collaboration with Novartis to identify new drug targets and therapeutics across a variety of disease areas. Epistem, which is focused on the regulation of adult stem cells located in epithelial tissue, is commercializing its expertise in the areas of oncology, gastrointestinal and dermatological diseases.

Texas Bill Would Create Research Consortium

To further adult stem cell research on the state level, Texas Senator Jane Nelson (R-Lewisville) and Chair of the Senate Health and Human Services Committee, has authored Senate Bill 73 that would create the Adult Stem Cell Research Consortium, which would encourage collaboration between researchers at Texas universities and cord blood banks. This body would oversee funding for adult stem cell research received from both public and private sectors.

If passed, the bill would move Texas beyond the debate about whether it is appropriate or inappropriate to destroy human embryos into the realm of adult stem cell research and treatments without ethical concerns. It is
estimated that more than 1.2 million Texans are afflicted with chronic degenerative conditions and can benefit from this research that could lead to the discovery of successful treatments and potential cures.

During March 2009 Texas Medical Association physician leader James T. Willerson, MD, who is President and Medical Director of Cardiology Research, and Codirector of the Cullen Cardiovascular Research Laboratories at Texas Heart Institute in Houston, and other authorities in the state’s adult stem cell field testified before senators at the Texas Senate Health and Human Services Committee meeting in Austin in support of Senate Bill 73.

Cord Blood Advancements Since 1st Transplant In cord blood technology, 2008 marked the 20th anniversary of the first cord blood transplantation in the world, carried out by Eliane Gluckman, MD, Ph.D. The recipient of that pioneering effort, Matthew Farrow, now 26 years old, continues in good health. He was born with a rare blood disorder and
was expected to die before the age of 10. When he was five his parents took part in a pioneering experiment in France to use stem cells from his sister’s umbilical cord when she was born.

Since then, cord blood stem cells have been used in more than 14,000 transplants worldwide to treat more than 70 diseases in both adults and children and are now showing great promise for regenerative medicine
applications, including treatment for type 1 diabetes, brain injury, cerebral palsy and hearing loss, according to Cord Blood Registry (http://www.cordblood.com), the world’s largest stem cell bank.

“As a result of pioneering work and the tremendous progress over the years, for many families cord blood banking is the best option for treating and curing disease, especially as they understand the importance of umbilical cord donations for advancing the science,” said Koos of Bio-Matrix Scientific Group.