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LOS ANGELES - UCLA researchers are seeking patients who have coronary artery disease and severe chest pain to volunteer for a Phase III, double-blinded study that will use the patients' own blood-derived stem cells to try to restore blood circulation to their damaged hearts.
This is one of the first stem cell studies for cardiac patients and it's for an unusual group, those who are either unable to receive traditional therapy or have already received traditional therapy that did not work, said Dr. Ali Nsair, an assistant professor in residence of cardiology and co-principal investigator for the study.
"We're hoping to offer patients who have no other options a treatment that will alleviate their severe chest pain and improve their quality of life," Nsair said.
Prior to receiving the direct injections of the stem cells into their hearts, researchers will first map the heart to study both the voltage and motion of the muscle. Damaged areas will not have as high voltage and movement as the undamaged areas," said Dr. Jonathan Tobis, a clinical professor of cardiology and co-principal investigator for the study.
"We will be able to tell by the voltage levels and motion which area of the muscle is scarred or abnormal and not getting enough blood and oxygen," Tobias said. "Then we can target the injections to the areas just adjacent to the scarred and abnormal heart muscle to try to restore some of the blood flow."
In the study, a patient's blood will be taken and CD34+ cells will be isolated from the rest of the blood. These cells will then be expanded and injected into the patient's heart using a catheter inserted into a groin artery and targeted to the damaged areas indicated by the mapping technique.
CD34+ cells are pluripotent, meaning they have the capability to turn into other cells. Tobis and Nsair hope these cells will either become new and healthy heart muscle cells or, more likely, the cells will stimulate the growth of new blood vessels, a process called angiogenesis. Those new vessels could provide better blood flow and oxygen to the heart muscle areas adjacent to the scarred and abnormal tissue.
The multi-center study seeks to enroll more than 440 patients nationwide. Earlier phase studies have shown the treatment is safe and patients in previous studies have reported some relief from their chest pain. Because the study is double-blinded, neither the patients nor the researchers will know who is getting the stem cell injection and who is receiving a placebo.
The three-armed study will have the double-blinded group of 222 volunteers who will receive the stem cells, 111 volunteers who will be given a placebo and 111 patients who will be treated according to the current standard of care. Patients will be followed for five years.
To qualify for this study, patients must have tried all possible conventional treatments and medications to treat their chest pain and still continue to be symptomatic. For more information about participating in this study at UCLA, call (310) 794-4797.
Tobis said another stem cell study is being planned at UCLA for patients immediately after suffering a heart attack. Patients who are candidates will be identified within four days after the heart attack and will have their stem cells harvested and injected into their hearts within 11 days to decrease the amount of damage to the heart.
This study, alto a multi-center study, will be launching at UCLA over the next couple of months.
Published: February 28, 2013 - Volume 11 - Issue 46