FDA Allows Cytori To Resume ADRC Trial In Ischemic Heart Disease
By Cyndi Root
Cytori Therapeutics has been allowed to resume its ATHENA trials for adipose-derived regenerative cells (ADRCs) in heart failure patients with ischemic heart disease. The company announced the trial resumption in a press release, stating the Food and Drug Administration (FDA) gave its approval on October 22, 2014. Cytori Therapeutics had placed enrollment in the ATHENA and ATHENA II trials on clinical hold in August 2014, stating that a safety review turned up cardiovascular risks.
Dr. Marc Hedrick, President and CEO of Cytori, said, “Cytori is first and foremost focused on patient safety in all its endeavors, and we are pleased to have successfully navigated this issue. Such issues are not uncommon in development programs involving novel technology for a severely ill population.”
ADRC Therapy
ADRCs improve the patient’s blood flow, moderate the inflammatory response, and rescue dying tissue. Adipose-derived regenerative cells (ADRCs) include adult stem cells, endothelial progenitor cells, leukocytes, endothelial cells, and vascular smooth muscle cells. They have advantages over bone marrow and embryonic stem cells, which include abundance in adipose tissue and ease of collection with liposuction. Autologous therapy, using the patient’s own tissue, limits tissue rejection and eliminates disease transfer
The ATHENA and ATHENA II clinical trials are placebo controlled studies to evaluate ADRCs in heart failure patients with ischemic heart disease who are already receiving maximal therapy with no options for revascularization. As Dr. Hedrick mentioned, the treatment process is novel and complicated. Investigators withdraw the patient’s own fat in a liposuction procedure, map the heart to locate optimal catheterization, and inject ADRCs on the same day as liposuction.
FDA Action
Cytori placed the ATHENA trials on hold due to a safety review of reported cerebrovascular events that occurred in three patients. The company reported the findings to the FDA, which requested that Cytori place the trials on hold until Cytori provided additional information to support trial resumption. The FDA has now agreed that Cytori’s new data and protocol amendments are sufficient to support the resumption of the trials. In August, Cytori said that the trial suspension would make it impossible to complete enrollment of the ATHENA I trial prior to the end of 2014. The company now says that it is assessing how the delay affects the trial and will provide an updated plan soon.