Cell therapy company Cytori Therapeutics recently announced the presentation of an update on the clinical trials SCLERADEC I and II, which are investigating the use of Cytori Cell Therapy in the treatment of scleroderma-related hand dysfunction, at the 104th Annual Meeting of the Japan Society of Aesthetic Surgery in Tokyo, Japan. The presentation, “New Strategy and Possibility for Using ADRCs for Treating Scleroderma,” was delivered by SCLERADEC I principal investigator Prof. Guy Magalon.
Magalon presented promising results on the now-completed two-year follow-up of the clinical trial SCLERADEC I. This clinical trial evaluated for the first time the efficacy, safety, and tolerability of Cytori Cell Therapy (ECCS-50), which is injected subcutaneously into the fingers of scleroderma patients who have experienced hand dysfunction due to the disease. ECCS-50 was developed and prepared by a team led by Prof. Florence Sabatier, according to European regulations.
The results from the SCLERADEC I pilot study have been published in the journal Rheumatology. The results indicated that patients treated with a single administration of ECCS-50 showed significant improvements in hand function and Raynaud’s phenomena, a disease that affects the blood vessels mostly in the fingers and toes, one year after treatment. The results were also recently presented at the Systemic Sclerosis World Congress.
“Hand involvement is common in scleroderma and few effective medical options exist,” said John Harris, vice president and general manager of Cell Therapy in a press release. “We are very grateful that Dr. Magalon is here in Japan highlighting the results of this seminal work. The timing coincides nicely with our development and partnering plans here in Japan that have the goal of bringing Cytori’s novel ECCS-50 therapy for hand scleroderma to the market.”
Cytori is currently recruiting patients for the Phase 3 STAR clinical trial, which aims to enroll 80 patients and has so far reached 75 percent of target enrolment. The STAR clinical trial is an U.S. FDA-approved placebo-controlled study that aims to investigate the efficacy and safety of ECCS-50, as delivered through a Celution device. The treatment involves the harvesting of adipose tissue though small-volume liposuction in order to isolate and concentrate adipose-derived regenerative cells (ADRCs), and then administer them to the fingers of patients. For more information about the STAR trial, please visit this link.