Clinical Trials and Current Research at the Stem Cell …

What is a clinical trial?

A clinical trial is a research study in which patients may volunteer to take part. The Stem Cell Center (SCC) at the Texas Heart Institute uses clinical trials to further the understanding of stem cells in relation to heart disease.

Clinical trials are part of a long, careful process, which may take many years. First, doctors study a new treatment in the lab. Then they often study the investigational treatment in animals. If a new research treatment shows promise, doctors then test it on people. Doctors do this in three to four steps, or phases. Phase I trials test to see if an investigational treatment is safe in people. Phase II trials test for efficacy. Phase III trials test if a new treatment is better than a standard treatment. Finally, the goal of Phase IV trials is to find more information about long-term side effects.

Is it safe?

The Stem Cell Center's most important job is to ensure the safety of patients.

First, the SCC ensures patient safety by following well-planned, FDA approved protocols. A protocol:

Second, the SCC ensures patient safety by using a careful informed consent process.

Third, our Institutional Review Boards (IRBs) protect patients by reviewing protocols and monitoring trials. The IRBs are committees of doctors, nurses, chaplains, social workers, lawyers and patients. They make sure that trials follow federal laws and that patients are protected.

The U.S. Food and Drug Administration (FDA) audits the IRBs' files. Also, FDA officials may visit the SCC at any time and review anything they choose related to clinical trials.

Am I able to take part?

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Clinical Trials and Current Research at the Stem Cell ...