Study Results Demonstrate Long Term Cell Survival and Quality of Life Improvements
LOS ANGELES-- (BUSINESS WIRE)--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.
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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.
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