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From rxpgnews.com Clinical Trials
The study, designated as the 'PRECISE' trial, will enroll patients suffering from chronic myocardial ischemia, a severe form of end-stage coronary artery disease, which is estimated to affect hundreds of thousands of patients in Europe and the United States. Patients in the study will receive their own adult stem and regenerative cells, thereby avoiding the risk of rejection or disease transmission that exists with donor stem cells and the controversy associated with embryonic stem cells. Once introduced into a patient's heart, the cells have shown preclinically to help the body improve blood supply that can restore circulation to the heart. "Patients with chronic heart disease today have few options making this an important milestone for the affected patients and doctors that treat them," said Marc H. Hedrick, M.D., President for Cytori Therapeutics. "This study is designed to show unequivocally whether the cells from our Celution System(TM) can be safely introduced into the heart. Our ultimate goal is to asses the clinical therapeutic effect of the cells, which were shown in preclinical studies to significantly improve heart function." Adipose Tissue: Rich Cell Source Adipose tissue, commonly known as fat, is the human body's richest known source of stem cells, as well as other cells that are believed to contribute to repair and healing, referred to as "regenerative cells." Due to its abundance and accessibility in the body, adipose tissue represents an ideal source for immediate access to a patient's own stem and regenerative cells. The Celution(TM) System For the PRECISE study, stem and regenerative cells are obtained at the bedside from the patients' own adipose tissue and made available in real-time using Cytori's Celution(TM) System. The Celution(TM) System automates and standardizes the complex process that releases stem and regenerative cells locked within adipose tissue. Adipose tissue is removed from the patient using a minor liposuction-like procedure, placed into the system and, with the touch of a button, processed. About an hour later, a prescribed dose of stem and regenerative cells are delivered to the patient. Clinical Trial Details The PRECISE study will evaluate the safety and feasibility of using adipose-derived stem and regenerative to treat 36 patients with chronic myocardial ischemia whom cannot be effectively treated by other means. The cells will be processed with the Celution(TM) System in the catheterization lab so they are available for the physician to re-inject into damaged heart muscle in about an hour using the NOGA(R) mapping and delivery system. A variety of clinical functional and imaging endpoints will be assessed in the study. The outcomes of the study will be evaluated after a six month follow-up period. The PRECISE study is being conducted at the Hospital General Universitario Gregorio (HGU G) Maranon in Madrid, Spain. Professor Francisco Fernandez-Aviles, professor of cardiovascular medicine and chief of cardiology service at HGU G Maranon, and Dr. Emerson Perin, director of the New Interventional Cardiovascular Technology and director of the Stem Cell Center at the Texas Heart Institute will serve as co-principal investigators. "Cytori's stem cell technology has the potential to become the next major advancement in cardiovascular disease care," said Dr. Aviles. "Their device is user-friendly and enables the delivery of patient's cells at the bedside without ever leaving the catheterization lab." "These cells may be optimal for targeting cardiovascular disease due to their ability to promote blood vessel growth," said Dr. Perin. "This primary mode of action demonstrated in pre-clinical studies could result in significant clinical benefit." All rights reserved by RxPG Medical Solutions Private Limited ( www.rxpgnews.com ) |
