Michigan CardioVascular Institute cardiovascular disease specialists at Covenant HealthCare have enrolled their first patient into a clinical trial of a novel gene therapy technique to promote regeneration of the heart in heart failure patients.

The study, being conducted by MCVI Research Department at Covenant HealthCare, is exploring the efficacy of an experimental gene drug designed to heal a damaged heart by encouraging the body to deploy more stem cells to site of the injury than it normally would.

Heart failure (HF) occurs when the muscle of the heart becomes weakened and cannot pump blood sufficiently. The injury is most often caused by inadequate blood flow to the heart resulting from ischemic cardiovascular disease, including heart attacks. Affecting more than five million people in the U.S., heart failure is a leading cause of death, disability and hospitalization.

Considerable scientific evidence has emerged over the past decade demonstrating the high therapeutic potential of stem cell-based regenerative medicine for a host of diseases. Stem cells are the building blocks for every organ, tissue and cell in the human body. They have the unique ability to develop into many different cell types, and in many tissues serve as an internal repair system, dividing essentially without limit to replenish other cells.

Dr. Safwan Kassas, principal investigator, said the way the human body deals with protein regulation will be the wave of the future for all of mankinds significant incapacitating diseases; the STOP-HF Trial is of paramount importance for the future of this type of therapy.

Sponsored by Juventas Therapeutics, the STOP-HF Trial is a randomized, placebo-controlled, double blinded Phase II study evaluating the safety and efficacy of the drug JVS-100 in patients with late-stage heart failure. JVS-100 is a gene therapy that directs the heart muscle to produce Stromal cell-Derived Factor 1 (SDF-1), a protein which has been shown to repair damaged tissue in the body through the recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow.

A Phase I study of JVS-100 in Class III ischemic heart failure patients met the primary safety endpoint and demonstrated clinically significant improvements at 12 months in exercise.

MCVI with Covenant HealthCare is one of just a dozen U.S. sites participating in the trial. The study will enroll 90 patients nationwide.

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MCVI joins study of new heart repair drug

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