Scleroderma is a condition that involves the skin and internal organs with patients often having blood vessel dysfunction, which can create Raynaud’s phenomenon in patients dealing with blood flow impairment to their hands and feet. The condition can also create excessive tissue fibrosis, which can lead to symptoms of thickening and scarring.
With Cytori’s Celution device, researchers determined that it was possible to isolate a population of fat tissue cells that are believed to have important therapeutic qualities. Adipose-derived regenerative cells (ADRCs) were found to be able to maintain and repair vessel structures, modulate inflammatory responses, and reduce fibrosis processes.
Results from earlier phases of the trial showed that scleroderma patients given ADRCs-based Habeo cell therapy for up to 12 months saw improved hand function and 30 to 35 percent improvement in vascular suppression score in their fingers. The study also showed that, among the patients who saw improvement, Raynaud’s phenomenon was reduced by 68 percent compared to starting levels.
The positive results support Habeo cell therapy’s therapeutic potential and allowed Cytori to continue its randomized, placebo-controlled STAR trial, which enrolled 88 participants who had limited hand function due to scleroderma. After the completion of the results from the trial, participants given the placebo will be offered the opportunity to switch to the Habeo cell therapy.
Cytori hopes the results of the STAR trial, which are expected in the third quarter of 2017, will support premarket approval submission on its Celution device to the U.S. Food and Drug Administration by 2018.