Cell therapy company Cytori Therapeutics announced that its Phase 3 STAR clinical trial has enrolled and treated its 60th patient, reaching 75 percent of the target enrollment (80 patients). Safety data review of the first 40 patients who were treated was positive, and an independent monitoring committee recommended that the clinical study should continue. The STAR clinical trial (NCT02396238) is still recruiting patients with hand dysfunction due to scleroderma.
The STAR study is a U.S. FDA-approved Phase 3 trial that aims to investigate the efficacy and safety of Cytori Cell Therapy (ECCS-50) delivered through a celution device. The treatment, designed to treat scleroderma patients who have experienced hand dysfunction due to the disease, begins with the harvesting of adipose tissue though small volume liposuction in order to isolate and concentrate adipose-derived regenerative cells (ADRCs), which are then administered to the fingers of the patients.
Cytori is conducting another study, SCLERADEC-II, a Phase 2 trial testing the efficacy of Cytori Cell Therapy ECSS-50 through subcutaneous injection.
The STAR trial follows the 12-patient SCLERADEC-I pilot trial, whose two-year results were announced in February at the Systemic Sclerosis World Congress in Lisbon, Portugal. The SCLERADEC-I trial evaluated for the first time the efficacy, safety, and tolerability of ECCS-50 and, according to the results, the patients treated with a single administration of ECCS-50 showed significant improvements in hand function and Raynaud’s phenomena, a condition that affects the blood vessels mostly in the fingers and toes, one year after treatment.
“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.
The company had announced in January an agreement with Idis to establish a Managed Access Program (MAP), which allows ethical access to their pre-license and unlicensed medicines for cellular therapy in selected countries across Europe, the Middle East, and Africa.
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