Barbados-based company funds breakthrough study
Published: June 7, 2005
A STUDY funded by the Barbados-based Institute for Regenerative Medicine, shows that advanced heart failure patients improved significantly after receiving stem cell therapy.
The findings of a small clinical trial performed at the Luis Vernaza Hospital in Guyaquil, Ecuador were officially released world-wide yesterday and showed that 30 days after receiving the stem cells by injection into their hearts, patients improved an average of 41 per cent in their heart’s pumping efficiency and the distance they could walk non-stop increase by 72 per cent in a standard test widely used to assess heart patients.
This is the first reported study to use human foetal- derived stem cell therapy in patients with heart failure. 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.
These results suggest a potential for changing the trajectory of heart failure …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.
Barnett Suskind, CEO
In the study, ten patients with advanced-stage heart failure underwent open chest surgery during which human foetal-derived stem cells were injected into their hearts. Patients were assessed for the severity of their heart failure before the procedure, as well as 30 and 90 days after, based on standard New York Heart Association (NYHA) criteria.
This included their hearts’ ejection rate, 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 tests.
One patient dropped out of the study as she had a stroke three 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 stem cells used in the study were provided by the Institute for Regenerative Medicine and prepared from foetal tissues from legally consenting, non- compensated donors outside the US 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.
Barnett Suskind, CEO
The Institute is 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.
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