Cell Therapy Foundation Calls for Additional Research, Extensive Clinical Trials

INDIANAPOLIS, Aug. 30 /PRNewswire/ — Some of the most promising medical
research conducted to treat diseases of the brain, heart, and circulatory system
is moving too slowly to help millions of patients, according to the Cell Therapy
Foundation, which advocates the use of adult stem cells to dramatically impact
and improve the condition of patients who suffer from a variety of conditions.

A Cell Therapy Foundation analysis of current clinical trials points to a
critical need: more federal, private, and philanthropic funding for adult stem
cell clinical trials. Key gaps exist between breakthrough developments in basic
research and translation to patients, revealing the essential need for funding
in this area.

One gap is in the transition from pre-clinical work to early clinical trials.
Another is in the progression from early clinical trials to larger, definitive
clinical studies. There is a clear need for development of new concepts and
funding strategies to bridge these gaps, building on already established
platforms or establishing new centers dedicated to translation of stem cell and
regenerative medicine research from the bench to the bedside.

“Remarkable work is being done, but we must find more funding to get the
critical research out of the laboratory and into practice, to help people with
new therapies that utilize adult stem cells as a catalyst for healing,” said Dr.
Sotirios Karathanasis, Vice President and Head of Bioscience in Astra-Zeneca,
and member of the advisory board of the Cell Therapy Foundation.

Headquartered in Indianapolis, IN, the Cell Therapy Foundation is a
not-for-profit organization committed to advancing research and the treatment of
disease using adult stem cells. To bolster awareness, the Cell Therapy
Foundation is highlighting clinical trials and centers that are dedicated to
translating new adult stem cell advances into patient therapies, particularly
focusing on disease areas that have not been previously addressed by standard
bone marrow approaches, or for which there is currently no adequate therapy via
more traditional therapeutic approaches.

In the USA, only a handful of such clinical trials have reached Phase III, the
stage prior to submission for regulatory approval. Phase III cell therapy
studies for heart disease, peripheral vascular disease and multiple sclerosis
have been initiated and are recruiting patients.

“Researchers need more support to move clinical trials along, addressing these
and many other critical diseases. Before a treatment can be approved, a
definitive clinical (“Phase III”) trial must show a positive impact to fight a
disease. The very limited number of Phase III trials, and even earlier (“Phase
II”) trials, illustrates the critical need for much more funding to be dedicated
to the area of adult stem cell therapeutics. The recent breakthroughs in our
understanding of stem cell and regenerative biology, and exciting early clinical
data, point to a future of a very different medicine, involving rescue or
replacement of damaged tissues by regenerated functional healthy tissues,
opening the way for true disease cures. These developments may revolutionize the
way medicine is practiced in the not-too-distant future, and such novel
approaches will provide new hope for many serious diseases that impact millions
of people,” added Dr. Karathanasis.

Among these Phase III trials currently underway in the United States:

Heart Disease: This heart disease trial is focused on testing whether
transplantation of muscle-derived stem cells will benefit patients with severe
and symptomatic heart failure. Initial results from this trial were presented at
the Heart Failure Society of America meeting and early indications from this
trial appear encouraging. It is sponsored by Bioheart, Inc., and its lead
investigator is Dr. Warren Sherman, Director, Stem Cell Research and
Regenerative Medicine, Columbia University Medical Center. Relevant to this, a
recently-reported breakthrough in this area is the demonstration that three
genetic factors alone are sufficient to reprogram non-embryonic cells from skin
into beating ventricular cardiomyocytes. This finding, if translated to humans,
will have important implications due to its potential for cell transplantation
from one part of the body to another part and even individualized therapy.

Vascular Disease: Biomet Biologics is sponsoring a pivotal study on peripheral
vascular disease using bone marrow aspirate concentrated at the point-of-care,
for patients with threatened amputation. The lead investigator is Dr. Michael P.
Murphy, Associate Professor of Vascular Surgery at the Indiana University School
of Medicine, and Clinical Director of the Vascular and Cardiac Center for Adult
Stem Cell Research.

Multiple Sclerosis: A trial addressing multiple sclerosis, sponsored by
Northwestern University, is evaluating the use of peripheral blood stem cell
transplants. The lead investigator is Dr. Richard Burt, Associate Professor,
Division of Immunotherapy at Northwestern University.

Cell Therapy Foundation

The Cell Therapy Foundation is a not-for-profit organization committed to
advancing the treatment of disease using adult stem cells. Emerging as a leader
in raising funds for adult stem cell research, Cell Therapy Foundation strives
to increase awareness about adult stem cells, to fund adult stem cell research
addressing several specific diseases, and to accelerate the rate of research and
clinical trials. http://www.celltherapyfoundation.org Contact: Kelli McLemore,
765-623-2884.

SOURCE Cell Therapy Foundation