Healthcare Industry News: organ transplant
News Release - November 7, 2007
Advanced Cell Technology Announces 12-Month Results of Myoblast Therapy TrialResults Presented at Late Breaking Trial Sessions at AHA Annual Meeting
ORLANDO, Fla.--(HSMN NewsFeed)--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’s annual meeting in Orlando, Florida.
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.com.
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," "expects," "estimates," 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 June 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.
Source: Advanced Cell Technology
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