For the first time, surgeons at the Methodist Hospital in Houston have injected highly-concentrated stem cells directly into a patient's heart, providing an intense, direct hit on damaged heart tissue.
The promising new technique can turn out to be more effective in regenerating healthy heart tissue than current methods that use a catheter to put standard stem cells through the bloodstream into the heart.
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"Some patients have such severe heart failure that their only current option is a heart transplant. We hope that stem cells will stimulate angiogenesis, the growth of new blood vessels, restore mechanical function in diseased heart tissue, and return patients to a much better quality of life without a transplant," said Dr. Brian Bruckner, cardiac surgeon at the Methodist DeBakey Heart and Vascular Center in Houston.
The new process requires the patient's strongest and most robust stem and progenitor cells, derived from the patient's own bone marrow, to be amplified up to 1,000 times before they're injected back into the patient's heart.
In the procedure, Dr. Bruckner made a small incision in the left side of the patient's chest and administered approximately 25 injections of concentrated stem cells into the patient's heart. All patients in the trial will be followed for 12 months after the injections.
A large number of people are suffering from chronic heart failure, and some of these individuals have dilated cardiomyopathy (DCM), a chronic heart disease in which the patient's heart can not pump effectively enough to deliver blood and oxygen to the vital organs in the body.
Patients with DCM typically experience severe limitations to physical activity and shortness of breath.
"Without a new approach to treatment of these patients, they will continue to decline and less than 40 percent will survive five years. We hope this trial will provide a completely new and viable treatment for them," said Bruckner, principal investigator for the trial.
The IMPACT-DCM trial is a randomized, controlled, prospective, open-label, Phase II study that will seek to enroll 20 patients with ischemic dilated cardiomyopathy (DCM) and 20 patients with non-ischemic DCM at five clinical sites in the U.S.
Participants must have a left ventricular ejection fraction of less than or equal to 30 percent (60-75 percent is typical for a healthy person) and meet certain other eligibility criteria.
All patients in each group will receive standard medical care and 75 percent of the patients will be treated with cardiac repair cells (CRC), a mixture of stem cells and progenitor cells derived from the patient's own blood marrow, through direct injection into the heart muscle during a minimally-invasive procedure in the operating room.
While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including left ventricular ejection fraction and other cardiac function parameters as well as heart failure stage will be monitored.
Patients will be followed for 12 months post treatment.
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