Advanced Cell Technology Announces 12-Month Results of Myoblast
Therapy Trial
Advanced Cell Technology, Inc. (OTCBB: ACTC) today announced that a
controlled, randomized clinical trial using ACT?s myoblast therapy
demonstrated marked improvement in heart failure symptoms after both
six and twelve months. ACT had already published 6-month data for the
trial. The positive 12-month results announced today demonstrate that
the effects of ACT?s myoblast therapy persist for an extended period
of time, an effect that has not been demonstrated for any other
cellular therapy for heart disease. The trial also showed evidence
that the hearts of the patients that received the therapy showed less
cardiac remodeling (an increase in the size of the heart that
signifies worsening of function) than did control patients. Principal
investigator Dr. Nabil Dib, Director, Clinical Cardiovascular Cell
Therapy, University of California, San Diego and Director of
Cardiovascular Research at Chandler Regional Medical Center and Mercy
Gilbert Medical Center, Phoenix, AZ, presented the results of the
trial today in a Late Breaking Clinical Trial Session at the American
Heart Association?
The trial marks the first time in the United States that scientists
performed a controlled, randomized clinical trial using catheter-
delivered muscle stem cells to treat congestive heart failure, a
condition marked by progressive weakening of the heart and failure of
the heart to pump blood properly. Patients with congestive heart
failure often have scar tissue in the heart, which limits the heart?s
ability to pump blood and contributes to continued atrophy of the
heart. Standard multi-drug therapy and surgery can help slow but not
stop the decline in heart function. Using these existing therapies,
ultimately patients have no treatment options besides heart
transplant or being outfitted with a mechanical pump to assist the
heart. The data presented today suggests that by using the ACT
technology doctors now have the opportunity to successfully replace
scarred heart tissue with healthy muscle via intracardiac injections
of autologous skeletal myoblasts (ASMs).
The clinical trial enrolled 23 patients with poor cardiac output and
congestive heart failure. The control group consisted of 11 patients
on standard drug therapy while the experimental group was given
varying doses of 30, 100, 300, or 600 million ASMs. Using a catheter
and transplanting ASMs into scarred tissue, the trial suggests that
new living muscle may be forming in the hearts of patients in the
study. The transplanted stem cells, harvested from the patients? own
muscles, are compatible with the body and avoid possible tissue
rejection that often accompanies organ transplantation. The procedure
uses a minimally invasive catheter approach, which reduces the risk
of surgical complications as no anesthesia is required and only a
small incision is necessary for catheter access. Patients can be
discharged within 24 hours of the procedure.
?In this study, we learned that there is hope for using the body?s
own reparative cells to help the failing heart,? said Dr. Dib. ?We
need to continue research in this area to determine if this kind of
procedure is effective in treating a larger, more diverse group of
patients.?
A Phase II human clinical trial is planned and will utilize 3-
Dimensional Guided Catheter-Based Delivery of Autologous Skeletal
Myoblasts for Ishemic Cardiomyopathy (CAuSMIC). The trial, which will
be open for enrollment in the next few months, will be led by
principal investigator Dr. Dib and will target patients who are not
eligible for angioplasty or coronary artery bypass surgery and who
continue to have poor quality of life despite receiving optimal
medial therapy or cardiac resynchronization therapy with a pacemaker
or defibrillator device.
?We are encouraged by the data Dr. Dib presented from the results of
our myoblast trial,? noted William M. Caldwell, IV, Chairman and CEO
of Advanced Cell Technology, Inc. ?The positive 12-month data
presentation represents 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.?
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.
http://www.ad-
news.de/Aktie/
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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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