Clinical trials using a novel approach are being planned locally as a next step toward healing heart failure with stem cell therapy.
WASHINGTON — If stem cell therapy does for humans what it can do for mice it will revolutionize the nature of treating heart failure. Clinical trials using a novel approach are being planned locally as a next step toward that goal.
“It’s huge,” said Stephen Epstein, director of Translational and Vascular Biology Research at MedStar Heart & Vascular Institute. “If successful, the impact will be enormous.”
Earlier mouse studies conducted by Epstein show that intravenous injections of mesenchymal stem cells (MSCs) pack a double punch. The treatment greatly reduced inflammation that’s believed to be responsible for heart deterioration and it helped heal failing mouse hearts.
“There’s a huge decrease in the inflammatory response that’s present and most amazingly, there’s a remarkable improvement in left ventricle function,” Epstein said. “So we’re very encouraged by that.”
The human trials Epstein is planning will test the same process on patients with the most severe form of heart failure. Those whose main heart pumping chamber is being assisted with left ventricular assist devices (LVADs).
If, as Epstein expects, there’s success with extremely sick LVAD patients he believes the treatment can move to less seriously ill patients and give doctors another therapy that will improve outcomes for all heart patients.
“Inflammation is one of the major mechanisms that lead to progressive deterioration of heart function, and by reducing the amount of inflation, we’re hoping that not only will we immediately improve heart function but we’ll eliminate or at least delay the inexorable progression to heart failure,” Epstein said.
Another critical aspect of the research will be its use of stem cells applied intravenously.
Stem cell heart treatments typically are applied directly into the heart which is difficult and impractical for what might need to be repetitive treatments over time.
“What we found in preclinical studies is that you don’t have to get them into the heart. Inflammation is a systemic disorder and all you have to do is suppress this systemic inflammatory response without getting stem cells to any major extent into the heart,” Epstein said.
The clinical trial is a preliminary study that’s expected to last about a year and a half. It’ll attempt to decrease the incidents of heart failure and death in 30 patients who have a 40 or 50 percent chance of seriously deteriorating over the next four years.
If all goes well, Epstein looks forward to what’s next.
“There’s such a need for additional therapy in heart failure in general that we’ll probably have a major study in all heart patient patients.”
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