Cytori Therapeutics, Inc. received a conditional investigational device exemption (IDE) approval from the Food and Drug Administration (FDA) to launch the STAR trial in order to evaluate Cytori Cell Therapy as a potential treatment for impaired hand function in scleroderma.

“Hand problems from scleroderma result in substantial distress, pain and impaired quality of life,” said Dr. Dinesh Khanna, Director, University of Michigan Scleroderma Program and a principal investigator of the STAR trial. “We need more effective therapeutic options for our patients. I was impressed by the single center French study with Celution processed adipose-derived regenerative cells in patients with scleroderma hand disability, and although it is limited by a small number of patients, it provides the data to support the larger, well-designed, randomized, controlled trial that we will be conducting,”

Scleroderma is a rare chronic autoimmune disorder related to skin fibrosis, wherein an overproduction of collagen causes destruction in blood vessels and in multiple organ systems, including the lungs. The name of the disease comes from the Greek: sclera, which mean “hard,” and derma, which means “skin.” About 300,000 Americans have the disease, a third of whom have the systemic form of scleroderma, which is marked by high mortality rates. About 80 percent of SSc patients are women and the common onset of the disease occurs between 20 and 50 years of age. SSc is not a contagious disease, nor is it directly hereditary. However, researchers are still trying to understand its origin and find a cure to address the unmet medical needs related to scleroderma, as diagnosis can be difficult and often goes unnoticed.

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Cytori’s Cell Therapy is supposed to repair and restore the tissue that has been lost or damaged because of scleroderma. The STAR trial is conditionally approved for a clinical, randomized, placebo controlled, double blind and pivotal trial. It will enroll 80 patients in twelve sites across the United States. The goal is to assess the safety and efficacy of a Cytori Cell Therapy single administration in patients suffering with scleroderma with hands and fingers affected. The STAR trial outcomes evaluation will be based on Cochin hand score, an already validated measure of hand function. The primary endpoint was measured 6 months after the single administration of placebo or the Cytori Cell Therapy being evaluated.