Preliminary data of Cytori Therapeutics’ STAR Phase 3 trial (NCT02396238) demonstrated that the company’s adipose-derived regenerative cells (ADRCs) are feasible for the treatment of patients with scleroderma-caused hand dysfunction.
The data will be presented in a poster at the Annual Meeting of the American College of Rheumatology (ACR)/AHRP on Nov. 15 in Washington, D.C.
Cytori uses human adipose tissue as the raw material to manufacture their cellular therapies. Cytori Cell Therapy comprises a heterogeneous population of specialized cells, including stem, lymphatic, immune, and mesenchymal and endothelial progenitor cells that can play a role in the healing process of patients with scleroderma-associated hand dysfunction and orthopedic disorders, among other diseases.
The ongoing STAR Phase 3 clinical trial is a placebo-controlled study evaluating the safety and effectiveness of Cytori Cell Therapy (ECCS-50) injected into the fingers of scleroderma patients who have experienced hand dysfunction due to the disease.
The treatment includes harvesting adipose tissue through small volume liposuction to isolate and concentrate ADRCs. The primary endpoint of the trial is the improvement in hand dysfunction up to 48 weeks after treatment as measured by Cochin hand score compared to a placebo. Secondary endpoints of the trial include the study of Raynaud’s syndrome and health-related quality of life.
The poster to be presented at the ACR meeting will describe the clinical procedures adopted in the STAR clinical trial, as well as the clinical characteristics of the 88 patients taking part in the study. Cytori will also present the trial’s preliminary blinded safety results.
“The preliminary data support the feasibility of using Cytori Cell Therapy in scleroderma patients with hand dysfunction,” Dinesh Khanna, MD, MS, lead author of the poster, said in a press release.
Khanna is the Frederick G.L. Huetwell Professor of Rheumatology, a professor of internal medicine in the Division of Rheumatology, and director of the University of Michigan Scleroderma Program.
“We remain focused on continuing execution and completion of the STAR study in the middle of 2017,” added Marc Hedrick, president and CEO of Cytori.
Earlier this year, Cytori reported that the treatment has been well-tolerated by patients in the STAR trial.
STAR follows the pilot study SCLERADEC-I, whose published results were presented at the Systemic Sclerosis World Congress in Lisbon, Portugal, in February 2016 demonstrated that a single dose of ECCS-50 was safe and led to significant improvements in hand function and Raynaud’s syndrome.
Scleroderma is an autoimmune disease in which the body’s own immune system attacks healthy tissues, resulting in a hardening and tightening of the skin and connective tissues due to excessive collagen deposition. About 90 percent of patients with scleroderma suffer from hand impairment, a condition for which there are currently no approved therapies.