March 9, 2009 - Cytori Therapeutics Inc. completed enrollment in its APOLLO trial to evaluate the safety and feasibility of adipose tissue-derived stem and regenerative cells, processed with the company’s Celution System, in the treatment of severe heart attacks.
The steering committee deemed, in concurrence with data safety and monitoring board (DSMB), that the safety and feasibility goal in APOLLO was met at the initial cell dose and that the procedure did not raise safety concerns. The steering committee also recommended that a pivotal study be conducted to further evaluate efficacy. The DSMB has indicated its willingness to work with the steering committee to plan and execute this pivotal study. Cytori plans to report results on the primary six-month follow up period for the APOLLO trial in late 2009.
“The company met its goals for the trial after finishing the first cohort of 12 patients,” said Marc H. Hedrick, M.D., president, Cytori Therapeutics. “Most importantly, we needed to show that the fat harvest could be done safely on sick heart attack patients and that we could re-deliver the stem and regenerative cells back to these patients through the coronary artery in the same surgical procedure early in the perimyocardial infarction period. In my view, this result is a major accomplishment for Cytori and the regenerative medicine field.”
The APOLLO trial is a prospective, double blind, placebo controlled, safety and feasibility study. It was designed to investigate up to four doses of cells consisting of 12 patients per each dose, with three patients receiving stem and regenerative cells to every one patient receiving placebo in each cohort. Assessments and observations made by the principal investors and DSMB factored into Cytori’s decision to complete enrollment after the first dose cohort and begin designing and seeking approvals to initiate a European pivotal study at this dose. Cytori is presently in discussion with its notified body in Europe to negotiate study size needed to show efficacy and achieve reimbursement.
At the recent sixth International Conference on Cell Therapy for Cardiovascular Disease hosted in January, Patrick Serruys, M.D., principal investigator for APOLLO, presented encouraging six month outcome data on the subset of cohort one patients, which had been evaluated thus far. Although Cytori remains blinded to treatment versus control, evaluation of this data was considered by both Cytori and the investigators in the determination to proceed to a pivotal trial.
For more information: www.cytoritx.com