Editor's Choice Main Category: Stem Cell Research Also Included In: Heart Disease Article Date: 14 Apr 2012 - 8:00 PDT

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The ORMC's leading researcher for the clinical trial, Vijaykumar S. Kasi, MD, PhD, an interventional cardiologist, director, Cardiovascular Research, explains:

The PreSERVE-AMI Study assesses the efficacy and safety of infusing stem cells obtained from a patient's bone marrow into the artery in the heart, which may have caused the heart attack in patients who received a stent to open the blocked artery after a specific heart attack history, such as STEMI.

A ST-Segment Elevation Myocardial Infarction (STEMI) is a critical type of heart attack that occurs due to the blood supply to the heart being blocked for a prolonged period of time, which affects a large area of the heart muscle and causes changes in the blood levels of key chemical markers.

The national, randomized, double blinded and placebo controlled study will involve approximately 160 patients, at about 34 sites, to evaluate the efficacy and safety of infusing stem cells obtained from a patient's bone marrow into the artery in the heart that may have caused the heart attack.

The surgeons will first insert a catheter into an incision in the patient's groin. Guided by an x-ray camera, the doctors will then position the catheter in the location of the heart artery where the stent was placed, before inflating a balloon within the stent and infusing either AMR-001, a cell therapy product comprised of stem cells taken from the patient's own bone marrow, or a placebo into the affected area.

Before the infusion is made, the patients undergo various tests, including an electrocardiogram, a cardiac MRI and a cardiac nuclear test. After the patient has received all screenings required, the doctors will perform a mini-bone marrow procedure, in which they remove stem cells from the bone marrow of the patient's pelvic bone with a special needle. The stem cells are subsequently processed in preparation for infusion. The bone marrow of patients randomized to receive placebo will be frozen and stored in case they require bone marrow for any reason.

More here:
Restoring Heart Muscle Function With Pelvic Bone Stem Cells

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