View Full Version : Cardiac Stem Cell Clinical Trial in Florida

04-02-2010, 11:18 AM
Stem Cell Research Offers Hope to Heart Failure Patients

If you or a loved one are one of the millions of children and adults in the United States suffering from congestive heart failure, there is reason now to be hopeful.

An effective treatment may be on the horizon, thanks to stem cell research being done by a company in Florida.

Heart failure doesn?t mean your heart stops working. It means your heart is not working as well as it should. It?s not pumping enough blood, perhaps because your heart doesn?t fill up with enough blood, or it doesn?t pump blood forcefully enough to the rest of your body. The main causes of heart failure are diabetes, high blood pressure, and coronary artery disease.
Coronary artery disease is also one of the leading causes of heart attacks, which happen when plaque blocks the flow of blood (and oxygen) to an area of the heart. This causes damage and even the death of heart tissue.
In adults, it takes time to develop heart failure, sometimes many years, as the pumping action of the heart gradually weakens. Sometimes only the right side of the heart can be affected. But most of the time both sides are affected.

If the right side of your heart has the condition, then your lungs won?t get enough blood. That means your lungs won?t pass along enough oxygen to your blood. You may then notice a build-up of fluid in your feet, ankles, legs, liver, abdomen, and sometimes in the veins in the neck.

If the left side of your heart is affected, then the rest of your body will not get enough oxygen from the blood. In both kinds of heart failure, you can be short of breath and tired all of the time.

Sometimes, heart failure can lead to a heart attack, also known as myocardial infarction.

According to the National Institutes of Health (NIH), as many as five million people in the United States suffer from heart failure, and 300,000 of these die every year.

Although there are different kinds of treatment for heart failure, no one has come up with a cure.

But progress is being made. One company is exploring the use of stem cells in heart failure patients to reverse the damage (scarring) in tissue after a heart attack.

The U.S. Food and Drug Administration has given the go-ahead to Sunrise, Fla.-based Bioheart, Inc., (BHRT) to begin a Phase I clinical trial for the company?s proprietary stem cell mixture to treat congestive heart failure.
Because this is a so-called Phase I trial, it will involve only a small number of patients, in this case 15.

The goal of any Phase I trial is to test both the safety and effectiveness of a new drug or treatment.

Bioheart?s trial will be conducted at different locations and will assess the safety and cardiovascular effects of implanting its stem cell mixture in congestive heart failure patients who have experienced a heart attack.
The mixture consists of stem cells from a patient?s own thigh muscle that have been modified to over-express a certain protein. The stem cells are injected directly into the scar tissue in the heart using a needle-tipped catheter inserted into the groin.

The company hopes to prove that its stem cell mixture can grow new heart muscle within the scar tissue that will in turn be able help the repair process.
Bioheart also hopes the procedure will improve the patient?s heart function, exercise capacity, and quality of life.

When it tested the stem cell mixture in earlier preclinical studies, heart function in the tested animal improved 54 percent compared to 27 percent for an earlier version of the mixture.

Meanwhile, heart function in animals treated with a placebo declined by 10 percent.

According to Bioheart, the preclinical studies also showed that its stem cell product candidate enhanced blood vessel formation in damaged hearts.
The company says its clinical trial will begin sometime this year. So results won?t be available for awhile.

But heart failure patients have at least a ray of hope that stem cell research will someday provide a viable treatment for their debilitating condition.


04-02-2010, 03:26 PM
Remember, a spokesperson from BioHeart will be hosting the Ask the Doctor for this month. Please send your questions to me via e-mail or private message. You can find me by clicking on Community, then Members, then B, then Barbara (just plain Barbara)