Cytori Discuss Importance Of ‘STAR’ Trial For Scleroderma Patients
Cytori Therapeutics, Inc announced that the information recently presented in San Francisco regarding the STAR trial, a pivotal clinical trial for scleroderma, is now available on Cytori’s official website.
Dr. Dinesh Khanna, Professor of Rheumatology and Associate Professor of Internal Medicine in the Division of Rheumatology and Director of the Scleroderma Program at the University of Michigan, attended the information session to present insights into Cytori’s STAR Trial, as he is also the head of the research project. Dr. Khanna has received several awards for his brilliant work in researching and treating Scleroderma, including the 2011 “Best Doctor of the Year” award given by the Scleroderma Foundation and the 2007 Spirit of Leadership Award.
In 2015, the STAR trial will enroll 80 patients in the United States. The trial will be a randomized, placebo-controlled study to assess both efficacy and safety of a one-time administration of ECCS-50, a cellular therapeutic by Cytori, in patients suffering with scleroderma and also with hand dysfunction.
Dr. Khanna said in a press release: “Scleroderma is a rare disease, affecting nearly 300,000 patients in the US. The systemic form, systemic sclerosis, is the focus of the STAR trial and has a prevalence of 60,000 – 70,000 patients. It is an agonizing disease that leads to hand impairment in nearly 90% of patients. Hand symptoms are the leading cause of disability in this patient population, more disabling than rheumatoid arthritis, and severely negatively impact quality of life and work productivity. In addition to general measures to protect the hand, patients require medications, which often are inadequate to control symptoms or prevent complications. This cohort of patients has a dire and unmet need for effective treatments.”
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A pilot trial demonstrated that after a one-time treatment of injections of over 4 million cells into each finger of test subjects, there was a 50 percent improvement in the scleroderma patients’ impaired hand function.
Robert Riggs, Scleroderma Foundation’s CEO, concluded: “The scleroderma patient community anxiously awaits the development of therapeutics that will provide a better quality of life for people with this complex disease. I applaud the work of Cytori Therapeutics and their scientific partners as they work to bring important therapeutic advancements to people living with scleroderma.”
