Cytori Therapeutics recently announced that its FDA-approved Phase 3 STAR clinical trial evaluating ECCS-50 has enrolled and treated its 80th patient, reaching 100 percent of its target enrollment. Because of the strong interest and fast screening across the trial clinical sites, additional patients will be enrolled, so the final enrollment will exceed the original target of 80 patients. All additional patients are scheduled to complete the final procedure early next month. Full results from the trial are expected by mid next year.
“The collaboration of our industry, health care professions, health care institutions, and patients has led to our ability to fully enroll the STAR trial ahead of schedule,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics in a press release. “We are now one step closer to having Cytori Cell Therapy available to patients suffering from hand problems due to scleroderma. It is critical that we remain focused on careful and accurate data collection through the follow-up period. Even though the patients, the investigators, and Cytori remain blinded, we can say that the procedures are feasible and were well-tolerated by the STAR patients.”
The clinical trial, titled “Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR),” is a Phase 3 randomized, double-blind, placebo-controlled, parallel group pivotal study evaluating the efficacy and safety of Cytori ECCS-50 therapy for subcutaneous injection into the fingers of patients with impaired hand function due to scleroderma. Of the 80 patients enrolled, half received treatment with ECCS-50, and half received a placebo substitute.
The double-blind period extends to 48 weeks, and after all patients have completed this period, those in the placebo arm can be treated with ECCS-50 if they desire and if they continue to be eligible.
STAR trial follows the 12-patient SCLERADEC-I pilot trial, the two-year results of which were announced in February at a presentation at the Systemic Sclerosis World Congress in Lisbon, Portugal. The data presented indicated that a single dose of ECCS-50 was safe, and led to significant improvements in hand function, symptoms, and Raynaud’s phenomena, even two years after the treatment was administered.
In January 2016, Cytori began to collaborate with Idis in a Managed Access Program (MAP) for its cellular therapeutic in countries across Africa, Europe and the Middle East for scleroderma patients with impaired hand function.
MAPs provide pharmaceutical and biotechnology companies with ethical and regulatory compliant strategic solutions for enabling a fast and efficient response to patient demand outside of traditional access routes. This means patients can get access to pre-license/unlicensed products they may benefit from.