News | March 09, 2009

Cytori Stem, Regenerative Cell Heart Attack Trial Deemed Feasible, Safe

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

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
New Jersey Researcher Exploring New Stem Cell Therapies for Heart Attacks
News | Stem Cell Therapies| August 04, 2017
In petri dishes in her campus laboratory at New Jersey Institute of Technology, Alice Lee is developing colonies of...
Overlay Init