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ACT and CHW Enter into Letter of Intent to Establish a Clinical Trial Research Site and Training Center for ACT's Myoblast Phase II Clinical Trial
ORLANDO, Fla.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB: ACTC - News) today announced that a controlled, randomized clinical trial led by Catholic Healthcare West’s Dr. Nabil Dib, M.D., M.Sc., F.A.C.C., using ACT’s myoblast therapy demonstrated marked improvement in heart failure symptoms after both six and twelve months. 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. Dr. Dib presented the results of the trial today in a Late Breaking Clinical Trial Session at the American Heart Association’s annual meeting in Orlando, Florida.
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The Phase 1 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, Director, Clinical Cardiovascular Cell Therapy, University of California, San Diego and Director of Cardiovascular Research at CHW’s Chandler Regional Medical Center and Mercy Gilbert Medical Center, Phoenix, AZ. “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.”
“Currently, there are no treatment options available to correct heart failure, only those that can slow its progression,” said David G. Covert, president and CEO of the CHW East Valley Service Area and Chandler Regional Medical Center. According to Covert, Dr. Dib’s findings are the culmination of seven years of prior clinical work to demonstrate the safety and utility of taking a patient’s own muscle stem cells to repair heart muscle damage. “Chandler Regional Medical Center and Mercy Gilbert Medical Center are proud to participate in developing this innovative treatment option for people living with heart failure. As we continue to develop our research program, our main focus is to translate this type of research into bedside standard of care.”
Advanced Cell Technology and Catholic Healthcare West today announced that the two parties have entered into a letter of intent (LOI) for a proposed exclusive business arrangement to establish a clinical trial research site and a North American regenerative medicine interventional cardiology training center for the aforementioned ACT Phase II myoblast cellular transplantation clinical study.
The 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 newly established relationship with CHW represents another step in our process of initiating a Phase II human clinical trial for our myoblast therapy. We look forward to working with such a prominent hospital group.”
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.com. |
