and unable to pump enough blood around the body
For the first time in human history, cardiac stem cells were used to repair the severely damaged hearts of 16 patients in a trial conducted by researchers from the University of Louisville in the US. “It could offer an entirely new option and a potential cure for patients who are now dying from heart failure,” said study author Dr. Roberto Bolli, director of cardiology at the University of Louisville in Kentucky. “The results are striking. While we do not yet know why the improvement occurs, we have no doubt now that ejection fraction increased and scarring increased.”
The ejection fraction or “pumping efficiency” of the hearts of eight patients had improved by more than a whopping 12%. These results tripled the 4% improvement the researchers were expecting to see.
“If these results hold up in future studies, I believe this could be the biggest revolution in cardiovascular medicine in my lifetime, ” said an impressed Professor Bolli.
The “Schipio” trial included a total of 23 patients, all of whom suffered heart failure due to a previous heart attack. Seven of these received standard care while the other sixteen were assigned to stem cell therapy. The groundbreaking treatment involved extracting cardiac stem cells (CSCs) from patients during bypass surgery. CSCs are self-renewing cells that rebuild hearts and arteries. After a purification process and a period of growth in the laboratory, the cardiac stem cells are then injected back into damaged regions of the patient’s hearts four months later. A million of these CSCs were injected into each patient via a balloon catheter, an expandable device used to open up arteries.
Interestingly, this small Phase I study was primarily designed to assess safety rather than effectiveness of the new, cutting-edge treatment. At the start of the study, the patients had an average left ventricular ejection fraction (LVEF) of 40% or lower. Normal LVEF is 50% or higher. Over a period of 4 months, patients who received the treatment saw an 8.5% improvement in LVEF, increasing to 12.3% after one year. LVEF did not change in the seven patients of the “control” group who did not undergo the cardiac stem cell therapy. MRI scans conducted on number of patients revealed that cardiac scarring had been reduced.
“Michael Jones, our first patient, could barely walk 30 feet [before treatment],” Dr. John H. Loughran said. “I saw him this morning. He says he plays basketball with his granddaughter, works on his farm, and gets on the treadmill for 30 minutes three times a week. It is stories like that that makes these results really encouraging.”
These findings are published in the online edition of The Lancet medical journal and will be presented at the American Heart Association’s Scientific Sessions meeting in Orlando, Florida. Now, Professor Bolli and his team intend on applying for funding a much bigger, multi-centre Phase II trial.
Professor Gerd Heusch from the University School of Medicine in Essen, Germany commented on the study in The Lancet: “The results from Scipio raise new optimism because the study is based on rigorous quality standards and the reported benefits are of an unexpected magnitude… we will have to see whether the further data will meet the promises of the present study. More patients will need to be followed up over a longer period.”
“Stem Cell Test Is ‘biggest Breakthrough in Treating Heart Attacks for a Generation’” The Telegraph. Telegraph Media Group Limited, 14 Nov. 2011. Web. 14 Nov. 2011.