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VIDEO: Expert discusses cell therapy for ‘no-option’ patients with refractory angina
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ORLANDO, Fla. — In this video exclusive, Timothy D. Henry, MD, provides investigator insight on the RENEW study, which evaluated use of granulocyte colony-stimulating factor mobilized CD34+ cell therapy as treatment for refractory angina.
“There are about 10 to 12 million Americans who have chronic angina and an increasing number of patients have significant CAD that is no longer amenable to coronary revascularization. These are so-called ‘no option’ patients,” Henry, interventional cardiologist and director of cardiology at Cedars-Sinai Heart Institute, said. “The number of options available for [these patients] right now are very limited.”
Henry presented results of the RENEW study at the Society for Cardiovascular Angiography and Interventions Scientific Sessions. The goal was to enroll 200 evaluable patients randomly assigned cell therapy, 100 evaluable patients assigned placebo injection and 100 evaluable patients assigned standard care. The study was stopped early in December 2013 by the sponsor (Baxter) due to strategic and financial decisions by the company, according to Henry.
In the 125 evaluable patients, results showed significant improvement in exercise time and a reduction in angina equivalent to that observed in earlier phase 1 and 2 studies.
“Unfortunately, there was an inadequate number of patients to definitively prove this,” Henry said. “... All of this is tantalizing evidence that CD34+ stem cells are an excellent therapy for patients with refractory angina, but unfortunately we still don’t have the definitive trial.”