The Phase 3 STAR clinical trial from Cytori Therapeutics recently enrolled and treated its 60th patient — 75 percent of target patient enrollment. The FDA-approved Phase 3 STAR study is assessing the one-year safety and efficacy of the Celution Therapy ECCS-50 in the processing of an autologous graft consisting of adipose (fat) derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
Additionally, the company announced that an independent data monitoring board has reviewed the safety data from the first 40 patients, and recommended the trial to be continued as protocoled. The 60 procedures have been successfully completed without complications.
“The pace of enrollment has exceeded our original planning and is an indication of the openness and hope from physicians and their patients in the potential for cell therapy as a viable option for scleroderma. Based on screening and scheduling of patients, completion of enrollment will occur by mid-June. We remain exceedingly grateful to the investigators, research staff, and especially the patients who have participated,” said Dr. Steven Kesten, chief medical officer at Cytori Therapeutics, in a press release.
Cytori provides Cytori Cell Therapy, a heterogeneous population of specialized cells, including stem cells, for the treatment of patients with scleroderma hand dysfunction, orthopedic disorders, urinary incontinence, and thermal burns combined with radiation injury.
A total of 80 patients with impaired hand function due to scleroderma are taking part in the STAR trial. More than 90 percent of patients with scleroderma have hand involvement. The primary endpoint of the STAR trial is to assess the Cochin Hand Function Score, measured six months following a single dose of ECCS-50 or a placebo. Other efficacy endpoints of the trial include the study of Raynaud’s phenomena and health-related quality of life.
After patients have completed the 48-week follow-up period of the study, patients in the placebo group will be eligible for crossover to the active arm of the trial.
The STAR study follows the SCLERADEC-I pivotal trial. Data of one year post-treatment was published in the journal Rheumatology last August 2015. Data of two-year post-treatment were presented at the Systemic Sclerosis World Congress in Lisbon, Portugal. The results demonstrated that a single dose of ECCS-50 was safe, and that patients had improvements in Raynaud’s phenomena and hand function two years post-treatment.
In 2016, Cytori entered an alliance with Idis to create a Managed Access Program (MAP) for its cellular therapeutic for patients with impaired hand function due to scleroderma in European countries, Africa, and the Middle East. MAP is an umbrella term used to define an ethical solutions-based approach to provide unapproved medicines for patients with unmet medical needs.