Scleroderma, also referred to as systemic sclerosis, is an uncommon, progressive disorder that can lead to substantial morbidity and disability. In particular, impaired function of the hands is a common manifestation of scleroderma and has significant impact on a person’s quality of life and productivity. Hand manifestations of scleroderma include Raynaud’s phenomena, sclerodactyly (swelling, fibrosis, contractures), ulcers, and calcinosis (calcium deposits), all of which result in discomfort, pain, and impaired function.

Currently, there are few, if any, pharmaceuticals being developed that address the underlying progressive pathophysiologic abnormalities responsible for impaired function, and in the absence of such therapies, most of the treatment has been dedicated to symptom relief and prevention of exposures that trigger worsening. However, analyses from other therapeutic applications of Adipose Derived Regenerative Cells (ADRCs) and a recently published clinical trial suggest that a cell-based approach for the treatment of hand dysfunction from scleroderma may be of significant benefit.

The use of ADRCs is not approved as a treatment for impaired hand function and Raynaud’s phenomena due to scleroderma in the U.S. However, preclinical and preliminary clinical data obtained by Cytori and others indicate that it is a promising area of investigation for doctors and scientists seeking therapy for patients who continue to have impaired hand function and Raynaud’s phenomena despite standard-of-care therapies. It is thought that the multiple actions of ADRCs may reduce inflammation and improve blood flow and thereby reduce pain and improve function. It is possible that the cells may slow progression of hand manifestations of scleroderma.

Cytori has conducted or provided support for several clinical trials that have evaluated the application of investigational ADRC treatment in areas such as cardiac disease, sports injuries, breast reconstruction, urinary incontinence, and scleroderma. The data obtained in these trials supports the continued investigation of ADRCs as a potential treatment in diseases such as scleroderma. Cytori is therefore conducting this clinical trial to explore the possible role of ADRCs in patients with impaired hand function due to scleroderma.