New York: Patients with advanced heart failure significantly improved after receiving stem cell therapy, according to results of a small clinical trial.
The study showed, 30 days after receiving the stem cells by injection into their hearts, patients improved an average of 41 percent in their hearts’ pumping efficiency and the distance they could walk nonstop increased by 72 percent in a standard test widely used to assess heart patients. After 90 days, the heart-pumping improvements were sustained and patients further improved the distance they could walk in the standard test, by an additional 16 percent compared to 30 days and doubled compared to baseline.
The study is the first to use human fetal-derived stem cell therapy in patients with heart failure. The surgical procedure was performed by Drs. Federico Benetti, Luis Geffner, Yuliy Baltaytis and Teodoro Maldonado at Luis Vernaza Hospital in Guayaquil, Ecuador. Advanced heart failure is an incurable and usually fatal condition; other than heart transplantation, current medical treatments cannot reverse the course of the disease, and only slow its progression or help control its symptoms.
“This is the first-ever study to use human fetal-derived stem cell therapy in patients with heart failure and, though from a small group of patients, the results are very compelling and demand additional research,” said Valavanur Subramanian, MD, Chairman of the Department of Cardiothoracic Surgery, Lenox Hill Hospital, New York City and the study’s senior investigator. “It was especially gratifying to see these patients, many of whom couldn’t walk more than a short distance without losing their breath, improve their ability to perform physical activities that are a part of everyday living,” he said.
Study and Findings
In the study, 10 patients with advanced-stage heart failure underwent open chest surgery during which human fetal-derived stem cells were injected into their hearts. Before and 30 and 90 days after the procedure, patients were assessed for the severity of their heart failure (stage 1-4), based on standard New York Heart Association (NYHA) criteria; their hearts’ “ejection fraction,” the portion of blood pumped out of a filled ventricle as a result of a heartbeat and a measure of heart pumping efficiency, measured by echocardiography; their performance on the standard “six-minute walk test,” a widely used clinical measure of functional capacity and endurance which predicts mortality in patients with heart failure; and their performance on a standard treadmill exercise tolerance test.
One patient had to drop out of the study as she had a stroke 3 days after the surgery and was unable to perform the 30-day follow-up tests, and another non-compliant patient who failed follow-up was excluded from analysis.
The study showed the eight analyzed study patients demonstrated significant improvements at 30 and 90 days vs. baseline measures:
An increase of 72.5 percent at 30 days and an additional 16.8 percent at 90 days in the distance completed while performing the six-minute walk test (275.0m to 553.8m)
Treadmill exercise tolerance test increase from 2.5 METs at baseline to 5.6 METs at 90 days (no 30-day follow-up was performed)
42.9 percent improvement in NYHA class (32.1 percent at 30 days and further 15.8 percent at 90 days, from 3.5 to 2.0)
41 percent increase in ejection fraction (26.6 percent to 37.5 percent at 30 days and sustained at 90 days)
“These results suggest a potential for changing the trajectory of heart failure,” said Barnett Suskind, CEO of the Institute for Regenerative Medicine, which provided the unrestricted grant for the study. “We are committed to supporting and performing stem cell research to move to therapeutic applications. We will follow these patients to obtain additional, longer-term data, as well as perform variations of the procedure in new patients as part of an extension of this study. In addition, we are currently evaluating stem cell therapy in a variety of other disease conditions, and we will begin additional studies in diabetes, neurological disorders, spinal cord injuries and other conditions over the next year.”
This was the first reported study involving human fetal-derived stem cells in heart failure patients. Researchers have reported on the use of adult stem cells from the patients themselves (autologous) to treat heart failure. Fetal- derived stem cells also have been used to treat other conditions, including blood and immune system disorders, spinal cord injuries, stroke and other neurological and eye disorders, and diabetes. Fetal-derived stem cells are thought to be able to develop into a wider range of specialized cells than are adult stem cells.
The stem cells used in the study were provided by the Institute for Regenerative Medicine and prepared from fetal tissues from legally consenting, non-compensated donors outside the U.S. who underwent terminated ectopic pregnancies, elective abortions or spontaneous miscarriages. Prior to use, the cells were screened for viral, bacterial and fungal pathogens, similar to but more rigorous than screening tests used for human blood and organs. Each patient received 60-80 million cells.