Investigational Clinical Research: Stem cell transplantation includes a variety of cells which have been used for testing in clinical trials:

  1. Skeletal muscle derived stem cells (myoblasts) are being explored as a potential new treatment for patients who are diagnosed with congestive heart failure. See myogenesis.
  2. Bone marrow derived stem cells (Mesenchyma stem cells). The purpose of these cells is to potentially improve the inflammatory process after a heart attack and to potentially halt the progression toward heart failure. See below "preserving deterioration of heart function after a heart attack."
  3. Peripheral blood derived stem cells (CD34). These cells are used for the formation of new blood vessels which may have the potential to increase the blood supply to improve refractory chest pain. These cells are being tested in patient who continue to have chest pain in spite of the standard treatment. See angiogenesis.

Building new heart muscle: Myogenesis

Heart failure patients: More than 2 million patients are admitted to US hospitals and almost half a million patients die per year in the United States. Clinical trials that use stem cells (myoblasts) are available to provide the patients with potential myocardial regeneration and to strengthen the hearts' pumping ability. The hope is that this will improve the quality of life and survival of patients. Heart attacks frequently lead to heart failure. Our research over the past seven years has shown that we can rebuild a new muscle in the area of the heart attack and replace scar tissue. The myoblasts can be isolated from 2-5 grams of skeletal muscle biopsy and expanded in the cell laboratory. The cells are then transplanted to the heart via catheter. We have developed the steps of catheter- based stem cell transplantation and can transplant the cells via a catheter. This procedure causes no more discomfort than a standard heart angiography (cardiac catheterization). The heart can be imaged in three dimensions, the area of the heart attack identified and the cells can be transplanted with very high accuracy to the area of the heart attack. The patient is awake during the procedure and can be discharged usually within 24 hours.

New heart muscle is expected to grow in 3 months' time.

The current clinical trial will include patients who are diagnosed with heart failure secondary to myocardial infarction, heart function less than 40% and those who continue to experience symptoms of fatigue, shortness of breath or chest discomfort.

Procedure: See the first case on the web www.myoblast.org. Link to Tom Brokaw. And best of the session of the AHA

Building new arteries: angiogenesis

Chest pain: More than 130,000 patients per year are newly diagnosed with refractory chest pain (called angina). They continue to experience chest discomfort despite the best standard medical therapy and revascularization. There is the potential of forming new blood vessels to increase the blood supply to the heart by transplanting stem cells isolated from the patient's own blood (CD34). The clinical trial is currently recruiting patients older than 18 years of age with significant chest pain impacting the quality of life and heart function is above 25%.

Show first case movie for CD34 isolation and catheter delivery.

Preserving deterioration of heart function after a heart attack: It is known that 2/3 of patients who suffer a heart attack will never have a full recovery even after opening the artery with angioplasty or bypassing the artery through a surgical procedure. The new potential of stem cells derived from bone marrow might prevent the deterioration of the heart after heart attack. These cells are taken from bone marrow of a donor and can be transplanted to the heart and area of a recent heart attack victim via a catheter. Although the cells are allogenic, no anti-rejection medications are required.

Currently, we are accepting patients in this clinical trial. The enrollment pre-requisites include patients who have suffered a heart attack within the last 60 days and where the artery has been opened successfully with angioplasty.