Cytori Therapeutics recently published a report of 12-month data from the Scleradec-I clinical trial studying hand dysfunction in people with scleroderma. Findings from the 12 patient trial, which was led by Dr. Brigitte Granel and Dr. Guy Magalon of the Assistance Publique des Hôpitaux de Marseille in France, is titled “Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up,” and was published August 4th in the journal Rheumatology.
Also known as systemic sclerosis, scleroderma is chronic hardening of the skin and connective tissues that can impact organs as well, such as the heart and lungs. Patients with scleroderma can experience manifestations of the disease both internally and externally, and in many cases the disease affects the use of the hands.
Cytori Therapeutics is a company that develops cell therapies from fat tissue. Cytori Cell Therapy™ (known as ECCS-50) mainly acts by improving blood flow, by affecting the immune system, and by promoting the repair of wounds. It may be useful for a variety of medical conditions, including scleroderma.
According to the research, one treatment with ECCS-50 improved impaired hand function caused by scleroderma. The scientists measured hand function using a standard, established test called the Cochin Hand Function Scale, and assessed overall health status using the Scleroderma Health Activity Questionnaire. Using these clinical tools, the investigators observed improvements from the start of the study by an average of 51.3% and 46.8% after one year. They also found that there was a 30.5% improvement from the beginning of the study to one year in grip strength and a 34.5% reduction of pain.
Another larger Phase III trial called Scleradec II will begin this year to study the effects of the treatment in individuals with scleroderma. In addition, Cytori has initiated the STAR study, a Phase III clinical trial of Cytori Cell therapy for hand problems in Raynaud’s syndrome in people with scleroderma. Raynaud’s syndrome is a spasm of the arteries, particularly in the fingers, that can occur in response to cold or vibration. It causes uncomfortable skin sensations such as burning, itching or a cold numbness. The STAR trial is a 80 participant trial that started enrolling subjects in August of 2015.
“The observation that the improvement in hand function and Raynaud’s phenomena that was seen at 6 months, persists to at least 12 months with a single administration of Cytori Cell Therapy should provide added optimism on the outlook of this therapy for patients and their families,” noted Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics. “The prolonged benefit across a number of concordant endpoints in these patients is very encouraging. The recent start of the STAR trial brings us a step closer to understanding what role Cytori Cell Therapy may have in scleroderma.”