Monday, Feb. 11, 2008
Advanced Cell Technology Announces Presentation of Results from
Myoblast Study at ISCTR World Symposium
Study Results Demonstrate Long Term Cell Survival and Quality of Life
Improvements
LOS ANGELES Advanced Cell Technology, Inc. (OTCBB: ACTC - News)
announced today that principal investigator Dr. Nabil Dib, M.D.,
M.Sc., FACC, presented results from a 23-patient study of ACT's
myoblast therapy for the treatment of congestive heart failure (CHF)
over the weekend at the International Society for Cardiovascular
Translational Research (ISCTR) World Symposium in San Diego, CA. Dr.
Dib presented the results as a case study of the successful
translation of a therapy from scientific research to the bedside. The
results of the study demonstrate long term cell survival in heart
failure patients as well as strong quality of life improvements as
measured by the New York Heart Association third party questionnaire,
the Minnesota Living with Heart Failure Questionnaire, and the 6
minute walk results (compared to continued deterioration by the
control group). Moreover, ACT's myoblast trial has been the only cell-
based, FDA-approved human clinical trial that has not required the
administration of anti-arrhythmic drugs or assist devices, which is
in contrast to trials for bone marrow-derived and other adult stem
cell therapies.
ISCTR is an annual meeting for basic and clinical scientist
practicing cardiovascular disease research sponsored by the
University California, San Diego, Catholic Healthcare West and the
International Society for Cardiovascular Translational Research. Dr.
Dib is Director, Clinical Cardiovascular Cell Therapy, University of
California, San Diego, and Director of Cardiovascular Research of
Catholic Health Care West's Chandler Regional Hospital and Mercy
Gilbert Medical Center near, Phoenix, Arizona.
Dr. Dib enrolled 23 patients at Arizona Heart Institute with poor
heart function and congestive heart failure. The control group
consisted of 11 patients on standard drug therapy while the treatment
group was given varying doses of 30, 100, 300, or 600 million
autologous skeletal myoblast (ASM) cells. After one year, the
myoblast therapy showed a favorable safety profile as compared to the
control group. Likewise, secondary measures showed improvements in
quality of life measures, improvements in measures of tissue regrowth
and potential improvement in heart function, while the control group
showed signs of heart failure progression on the same measures. The
data from the study support conducting larger double-blind, placebo
controlled studies. A Phase II human clinical trial has been reviewed
and cleared to commence by the FDA. The planned Phase II trial will
be conducted at multiple clinical centers across the country
including in Arizona and California.
Patients with CHF due to myocardial infarction (damage in heart
muscle) often have scar tissue in the heart, which limits the heart's
ability to pump blood. In spite of optimal medical therapy and other
current heart failure treatments, in the United States alone 2
million patients per year are admitted to the hospital for CHF and
almost one-half million die annually. Doctors may now have the
opportunity to successfully replace scarred heart tissue with healthy
muscle via intracardiac injections of ASM stem cells from the
skeletal muscle.
"In this study, we learned that ASM cell transplantation using a
minimally invasive catheter system is safe, showed improvement in
measures of quality of life, and may have the potential to improve
cardiac function and electrical activity," said Dr. Dib. By using a
catheter and transplanting ASM cells into scarred tissue, new living
muscle can potentially be formed with limited risk to the patient.
Since the transplanted stem cells are harvested from the patient's
own skeletal muscles, the cells are compatible with the body,
avoiding possible immune system and tissue compatibility
complications. The procedure poses less risk than surgical procedures
because no anesthesia is required and only a small incision is
necessary for catheter access. Patients can be discharged within 24
hours of the procedure.
"We are honored that the ISCTR chose our myoblast therapy as the
centerpiece for discussing how best to translate research from the
bench to the bedside," stated William M. Caldwell, IV, Chairman and
CEO of Advanced Cell Technology, Inc. "We remain encouraged by the
data Dr. Dib presented and believe the positive 12-month data
represent another step in our process of initiating a Phase II human
clinical trial for our myoblast therapy. We look forward to moving
the myoblast and other stem cell therapies through the clinic and
ultimately to patients in need of treatment." In addition to nearing
the commencement of Phase II human clinical trials for the myoblast
therapy, ACT recently completed a pre-IND meeting with the FDA for
its RPE program for the treatment of retinal degenerative disease.
Should ACT successfully file an IND for its RPE therapy, the company
plans to move forward with Phase I human clinical trials, which would
position ACT with two therapies in human clinical trials as well as a
third, the hemangioblast program for the treatment of blood and
cardiovascular indications, in preclinical trials.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying
cellular technology in the emerging field of regenerative medicine.
The company operates facilities in California and Massachusetts.
For more information, visit www.advancedcell.
Forward-Looking Statements
Statements in this news release regarding future financial and
operating results, future growth in research and development
programs, potential applications of our technology, opportunities for
the company and any other statements about the future expectations,
beliefs, goals, plans, or prospects expressed by management
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements that
are not statements of historical fact (including statements
containing the
words "will," "believes," "plans," "anticipates,
s," and similar expressions) should also be considered to be forward-
looking statements. There are a number of important factors that
could cause actual results or events to differ materially from those
indicated by such forward-looking statements, including: limited
operating history, need for future capital, risks inherent in the
development and commercialization of potential products, protection
of our intellectual property, and economic conditions generally.
Additional information on potential factors that could affect our
results and other risks and uncertainties are detailed from time to
time in the company's periodic reports, including the report on Form
10-QSB for the quarter ended September 30, 2007. Forward-looking
statements are based on the beliefs, opinions, and expectations of
the company's management at the time they are made, and the company
does not assume any obligation to update its forward-looking
statements if those beliefs, opinions, expectations, or other
circumstances should change.
Forward-looking statements are based on the beliefs, opinions, and
expectations of the company's management at the time they are made,
and the company does not assume any obligation to update its forward-
looking statements if those beliefs, opinions, expectations, or other
circumstances should change.
Chad Griffin Consulting, Inc. Media: Jordan Markwith, 310-888-3523 or
Investors: CEOcast, Inc. Daniel Schustack, 212-732-4300
http://www.centreda
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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