Promising Scleroderma Clinical Trial May Improve Hand Dysfunction

Promising Scleroderma Clinical Trial May Improve Hand Dysfunction

Cytori Therapeutics provided a recent update on results from clinical trials assessing the use of Cytori Cell Therapy (ECCS-50) in the treatment of scleroderma-related hand dysfunction.

The presentation was made during the 104th Annual Meeting of the Japan Society of Aesthetic Surgery, May 17-18, in Tokyo, Japan.

Scleroderma is a group of rare diseases that involve the hardening and tightening of the skin and connective tissue fibers that provide the body’s framework and support. The condition can affect several organs, including the lungs.  In Japan, scleroderma is estimated to affect 27,800 people.

Dr. Guy Magalon presented the findings of the SCLERADEC-I trial in the presentation “New Strategy and Possibility for Using ADRCs for Treating Scleroderma.

Adipose-derived regenerative cells (ADRCs) consist of a mixture of several cell types such as adult stem cells, vascular endothelial cells, and vascular smooth muscle cells, and others that modulate inflammation, angiogenesis, and reduce or remodel fibrosis. Magalon showed that ADRC therapy, prepared through Cytori’s Celution System, offers a sustained benefit over a two-year period.

“Hand involvement is common in scleroderma and few effective medical options exist,” said Cell Therapy’s  vice president and general manager John Harris, 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.”

The Phase 3 STAR clinical trial enrollment phase should be complete by mid-June.

The STAR study follows the SCLERADEC-I pivotal trial. Data at one year post-treatment was published last year. Data of two-year post-treatment were presented at the 4th Systemic Sclerosis World Congress in Lisbon, Portugal, showing that two-years post treatment, a single dose of ECCS-50 therapy improved hand symptoms, function and Raynaud’s phenomena.

Cytori Cell Therapy (ECCS-50) is an heterogeneous population of specialized cells, including stem cells, being developed for the treatment of patients with scleroderma hand dysfunction, but also for other conditions, including orthopedic disorders, urinary incontinence, and thermal burns combined with radiation injury.

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