Cytori Therapeutics recently announced that its Phase 3 STAR clinical trial, evaluating the efficacy and safety of Cytori Cell Therapy in scleroderma patients with hand impairment, has treated its 20th patient to reach 25 percent of its enrollment and treatment goal. The trial is continuing on the recommendation of an independent monitoring committee that evaluated safety data obtained from the first 10 patients.
The STAR clinical trial (NCT02396238), currently recruiting participants, is a placebo-controlled Phase 3 study of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of scleroderma patients who have experienced hand dysfunction due to the disease. The treatment includes the harvest of adipose tissue through small volume liposuction to isolate and concentrate adipose-derived regenerative cells (ADRCs), which are then administered to the fingers of the patients.
The trial aims to recruit a total of 80 patients, to be randomly assigned into a placebo group and the ECCS-50 group. After a 48- week follow-up period, placebo patients can join the active treatment group. Enrollment is expected to be completed by mid-2016.
The company also reported that the treatment has been well-tolerated by patients in the STAR trial.
The Phase 3 trial follows the pilot study SCLERADEC-I, whose published results indicated that patients treated with a single administration of ECCS-50 had significant improvements in hand function and Raynaud’s phenomena, a disease that affects the blood vessels mostly in the fingers and toes, one year after treatment. Data regarding a two-year follow-up in patients with hand dysfunction associated with scleroderma who were treated with Cytori Cell Therapy will be presented at the 4th World Systemic Sclerosis World Congress, set for Feb. 18-20, 2016, in Lisbon, Portugal.
“We are very encouraged by the study progress and the commitment of our study centers to the STAR trial. In addition, we have been able to demonstrate that same day fat harvest, cell processing and finger injection is feasible and has been performed safely in multiple U.S. centers, as was demonstrated in the single center SCLERADEC-I trial performed in France,” Dr. Steven Kesten, chief medical officer for Cytori Therapeutics, said in a press release.
Eligible patients interested in possibly participating in STAR can find more information through the clinical trial’s website.