CHW Researcher Presents Results of ACT-Sponsored Trial Demonstrating Efficacy of ACT Myoblast Therapy for Heart Failure at AHA Meeting.ACT and CHW CHW Chicago White Sox CHW Catholic Healthcare West CHW Children's Hospital at Westmead (Australia) CHW Children's Hospital of Wisconsin CHW Community Health Worker CHW ChileHardware (Spanish website) Enter into Letter of Intent to Establish a Clinical Trial Research Site and Training Center for ACT's Myoblast myoblast /myo·blast/ (mi´o-blast) an embryonic cell which becomes a muscle cell or fiber.myoblas´tic my·o·blast n. A primitive muscle cell having the potential to develop into a muscle fiber. Phase II Clinical Trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II ORLANDO, Fla. -- Advanced Cell Technology, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : ACTC ACTC Apple Certified Technical Coordinator ACTC Almaden Cycle Touring Club ACTC Associated Colleges of the Twin Cities ACTC All Ceylon Tamil Congress (Sri Lanka) ACTC Association Canadienne de Télévision par Câble ) today announced that a controlled, randomized clinical trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. 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 remodeling /re·mod·el·ing/ (re-mod´el-ing) reorganization or renovation of an old structure. bone 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. The Phase 1 trial marks the first time in the United States Time in the United States, by law, is divided into nine standard time zones covering the states and its possessions, with most of the United States observing daylight saving time for part of the year. that scientists performed a controlled, randomized clinical trial using catheter-delivered muscle stem cells to treat congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , 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 autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. 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 re·par·a·tive also re·par·a·to·ry adj. 1. Tending to repair. 2. Relating to or of the nature of reparations. cells to help the failing heart," said Dr. Dib, Director, Clinical Cardiovascular Cell Therapy, University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report.[3] It is a Public Ivy. [1] For graduate studies, most of UCSD's Ph.D. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 Catholic Healthcare West (CHW) is a California not-for-profit public benefit corporation that operates hospitals in California, Arizona, and Nevada[1]. As such, it is exempt from federal and state income taxes. today announced that the two parties have entered into a letter of intent (LOI LOI Letter of Indemnity (international trade and carriage business) LOI Letter Of Intent LOI Loss On Ignition LOI Letter of Inquiry LOI Lack Of Information LOI Lack of Interest LOI Letter of Invitation LOI List Of Items ) 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 Cardiomyopathy Definition Cardiomyopathy is a chronic disease of the heart muscle (myocardium), in which the muscle is abnormally enlarged, thickened, and/or stiffened. (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 Coronary artery bypass surgery, also coronary artery bypass graft surgery, and colloquially heart bypass or bypass surgery is a surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease. and who continue to have poor quality of life despite receiving optimal medial therapy or cardiac resynchronization therapy with a pacemaker or defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a 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. About Catholic Healthcare West Catholic Healthcare West (CHW) is the eighth largest hospital system in the nation and one of the largest not-for-profit hospital providers in the West. Founded in 1986, the CHW network of more than 8,500 physicians and approximately 50,000 employees serve a population spanning 22 million people at 43 hospitals across California, Arizona, and Nevada. CHW is committed to delivering compassionate, high-quality, affordable healthcare services with special attention to the poor and underserved. In fiscal year 2007, CHW provided $922 million in charity care, community benefits, and unreimbursed patient care. CHW facilities in Arizona include Chandler Regional Medical Center, Mercy Gilbert Medical Center, St. Joseph's Hospital and Medical Center St. Joseph's Hospital and Medical Center is a hospital in Phoenix, Arizona, USA. It is currently operated by Catholic Healthcare West. Services St. Joseph's is a certified level I trauma center for adults. and Barrow Neurological Institute, CHW Urgent Cares in Ahwatukee, Gilbert and Queen Creek, Warner Outpatient Surgery and the Arizona Orthopedic Surgical Hospital. For more information, please visit our Website at www.chwHEALTH.org. About Chandler Regional Medical Center Chandler Regional Medical Center is a 225-bed, acute-care, non-for-profit provider of emergency care, maternal child services, cardiovascular services, wound healing, cancer treatment, diabetes treatment, and diagnostic services. It is located at 475 S. Dobson Road (corner of Dobson Road and Frye Road) in Chandler. For more information, please visit www.chandlerregional.org or call 480-728-3000. Chandler Regional Medical Center is an Equal Opportunity Employer equal opportunity employer An employer or enterprise that does not discriminate against a job candidate, or subject him/her to adverse exclusionary criteria, based on race, sex, religion, or national origin. See Equal employment opportunity. (EOE EOE See: European Options Exchange ). For employment opportunities please contact the Human Resources Department at 480-728-3424. About Mercy Gilbert Medical Center Mercy Gilbert Medical Center is located at the intersection of Val Vista Drive and Loop 202 (south of Pecos Road and east of Val Vista Drive). Mercy Gilbert Medical Center is a four-story, full-service acute-care facility with 92 beds. Expansion of the second tower is underway and will open in January 2008 adding 90 beds and a pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. and adolescent unit. For more information, please visit www.mercygilbert.org or call 480-728-8000. Mercy Gilbert Medical Center is an Equal Opportunity Employer (EOE). For employment opportunities please contact the Human Resources Department at 480-728-8396. About the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. Founded in 1924, the American Heart Association today is the nation's oldest and largest voluntary health organization dedicated to reducing disability and death from diseases of the heart and stroke. These diseases, America's No. 1 and No. 3 killers, and all other cardiovascular diseases claim over 870,000 lives a year. In fiscal year 2005-06 the association invested over $543 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. For more information, please visit www.americanheart.org. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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