Cytori Therapeutics will present data from its Phase 3 STAR clinical trial (NCT02396238) assessing the safety and effectiveness of adipose-derived regenerative cells (ADRCs) for the treatment of hand dysfunction due to scleroderma, an auto-immune disorder that can lead to the development of Raynaud’s syndrome.
The data will be presented in a poster at the Annual Meeting of the American College of Rheumatology (ACR/ARHP) on Nov. 15 in Washington, D.C.
The poster information will include the procedures of the STAR study, patient characteristics, and preliminary safety data for the use of ADRCs (ECCS-50 therapy) in scleroderma patients for the treatment of hand dysfunction.
Scleroderma is characterized by the development of fibrosis in the skin and other organs and dysfunction of blood vessels. In most patients, this disease is associated with Raynaud’s syndrome, as abnormalities in blood vessels contribute to impaired blood flood in the hands and feet, the hallmark of Raynaud’s.
The STAR trial includes 88 scleroderma patients, assigned to receive either a placebo or ADRCs. Patients under local anesthesia undergo a small volume liposuction for the collection of fat cells. These cells are processed in Cytori’s Celution System to isolate and concentrate ADRCs for immediate subcutaneous administration, under local anesthesia, into all fingers of both hands.
Improvement in hand function is measured by the Cochin Hand Function Score as compared to a placebo. Other assessments include Raynaud’s Condition Score and Scleroderma Health Assessment Questionnaire (SHAQ), among others, for up to 48 weeks. At the end of the study, placebo-treated patients will be offered treatment with ADRCs if they continue to qualify, according to the study criteria, and if they wish to continue.
The ADRCs prepared with Cytori’s Celution System are believed to regulate inflammation, promote the formation of new blood vessels (angiogenesis), and prevent cell death. Previous studies suggested that ADRC therapy may change the inflammatory response and increase the regenerative response that starts early in the injury process.
“The preliminary data support the feasibility of using Cytori Cell Therapy in scleroderma patients with hand dysfunction,” Dinesh Khanna, MD, professor of rheumatology, director of the University of Michigan Scleroderma Program, and the poster’s lead author, said in a news release.
“We remain focused on continuing execution and completion of the STAR study in the middle of 2017,” said Marc Hedrick, president and CEO of Cytori.