Cytori Therapeutics recently announced that its FDA-approved Phase 3 STAR clinical trial on ECCS-50 has enrolled and treated its 40th patient, reaching 50 percent of its target enrollment. Additionally, an independent data monitoring committee recommended the continuation of the study as previously determined.
The STAR trial follows the 12-patient SCLERADEC-I pilot trial, whose two-year results were announced in February at a presentation at the Systemic Sclerosis World Congress in Lisbon, Portugal. The data presented at the Congress indicated that a single dose of ECCS-50 was safe and led to significant improvements in hand symptoms, function, and Raynaud’s phenomena, even two years after the treatment was administered.
Previous one-year post-treatment results had been published in the August 2015 issue of Rheumatology, titled “Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up.”
Up to 80 patients will be randomly enrolled in the STAR trial, half of whom will receive treatment with ECCS-50, and half will receive a placebo substitute. The clinical trial, titled “Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR),” is a randomized, placebo-controlled, double-blind, parallel group Phase 3 pivotal study, which will evaluate the efficacy and safety of Cytori ECCS-50 therapy for subcutaneous injection into the fingers of patients who suffer from impaired hand function due to scleroderma.
The double-blind period will be extended to 48 weeks, after which placebo patients can choose to receive the active treatment. Enrollment began in August 2015, and enrollment completion is expected by the end of the June (see contacts and locations for more information about enrollment in the trial).
“We remain encouraged by how well the trial procedures have been tolerated and how the procedures have been instituted across the 20 study sites around the country. We are grateful to the investigators, research staff and especially the patients who have participated and enabled us to remain on track to complete enrollment in mid-2016,” Dr. Steven Kesten, Cytori’s chief medical officer, said in a press release.
Cytori entered into an agreement with Idis, announced in January, to establish a Managed Access Program (a tool that enables biopharma companies to access their pre-license/unlicensed medicines in an ethical way to help patients with unmet medical needs) for its cellular therapies in certain European, Middle Eastern and African countries to help patients with scleroderma-related impaired hand function.