Cytori Therapeutics recently revealed three-year clinical follow-up data of the SCLERADEC I trial (NCT01813279), showing that the improvement provided by a single dose of its ECCS-50 in hand dysfunction associated with scleroderma can be maintained over time in patients.
These results are in line with the recently published data obtained in the first two years of the follow-up evaluation after the trial.
The SCLERADEC I trial was conducted in France and investigated the safety of subcutaneous injection of autologous adipose-derived stromal vascular fraction (ECCS-50) into the fingers of 12 patients with hand dysfunction associated with scleroderma.
Results showed that patients treated with a single dose of ECCS-50 had significant improvements in hand function and Raynaud’s phenomenon, a scleroderma-related disease that affects blood vessels mainly in the fingers and toes.
The new analysis showed that, three years after the injection of ECCS-50, patients maintained the improvement, namely in four parameters: the Cochin Hand Function Score, scleroderma-related disability and pain, and Raynaud’s Condition Score.
Also, 83 percent of the patients had no symptoms of Raynaud’s phenomenon in the weeks before each follow-up assessment. Patients also maintained their improvement in hand strength and mobility scores since baseline.
“The longevity of the clinical response of a single therapeutic administration of ECCS-50 is an importing finding,” said Marc Hedrick, president and CEO of Cytori, in a news release. “As we prepare for commercial launch and interview payors, duration of effect seems to be one of many potentially attractive aspects of the therapy when compared to current available options.”
Cytori Cell Therapy is under evaluation in another clinical study, the STAR trial (NCT02396238), a Phase 3, placebo-controlled study in the U.S. also for patients with hand dysfunction associated with scleroderma.
The treatment involves the collection of adipose tissue though small-volume liposuction to isolate and concentrate adipose-derived regenerative cells (ADRCs), which are then administered into the fingers of 88 patients. Like the SCLERADEC I study, the objective is to evaluate effects on hand dysfunction and Raynaud’s phenomenon associated with scleroderma.
Analysis of results from the STAR trial will start when the last patient has completed the 48-week follow-up period, expected to occur in mid-2017.