The Phase 3 STAR trial investigating the safety and effectiveness of a cell therapy based on adipose-derived regenerative cells (ADRCs) for the treatment of hand dysfunction due to scleroderma has completed the full 48-week follow-up program approved by the U.S. Food and Drug Administration (FDA).
Patients with scleroderma can experience blood flow impairment affecting their hands and feet — hallmarks of Raynaud’s phenomenon — that can severely reduce their quality of life.
Scleroderma is characterized by an increased activation of cells responsible for the formation of connective tissue. The condition involves the skin and internal organs, and patients often have blood vessel dysfunction and excessive tissue fibrosis with symptoms of thickening and scarring.
With Cytori Therapeutics‘ Celution device it is possible to isolate a population of cells that are found in human fat tissue, the ADRCs. These cells are believed to have important therapeutic qualities, such as maintaining and repairing vessel structures and function, modulation of inflammatory responses, and reduction of fibrosis processes.
Previous results of the Phase 1 SCLERADEC I clinical trial (NCT01813279) showed that scleroderma patients who received Cytori’s ADRCs-based Habeo cell therapy (ECCS-50) for up to 12 months presented hand function improvement with reduced Raynaud’s phenomenon by 68 percent compared to levels at the study’s start.
In addition, treated patients were seen to have a 30 to 35 percent improvement in vascular suppression score in their fingers.
These positive results support Habeo’s therapeutic potential and the continued development of Cytori’s cell therapy program.
Currently ongoing, the randomized, placebo-controlled STAR trial (NCT02396238) enrolled 88 participants who presented hand function impairment caused by the autoimmune disease scleroderma. The patients received Cytori’s Habeo cell therapy or a placebo subcutaneously in their fingers.
According to a press release, the final 48-week visit to patients enrolled in the trial was recently conducted. Initial results of the STAR trial are expected in the third quarter of 2017.
After the evaluation of trial results, patients who received the placebo will be offered the opportunity to switch and receive the Habeo cell therapy.
Cytori expects that the results of the STAR study will be able to support a premarket approval (PMA) submission on its Celution device to the FDA by 2018.