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.
If you (or someone you know) have impaired function of the hands and Raynaud’s phenomena due to scleroderma, you may be interested in the STAR clinical trial.
The STAR clinical trial is designed to study the use of a patient’s own Adipose-Derived Regenerative Cells (ADRCs), prepared using the investigational Celution® Device, in the treatment of scleroderma affecting the hands and fingers. The study will be conducted in patients who are currently on medical therapy and still have impaired hand function and Raynaud’s phenomena.
The STAR clinical trial will enroll 80 patients in multiple centers in the United States. The study doctor and team will assess whether or not you are eligible to participate in the study. However, the major qualifications to participate in this study are:
- Age between 18 and 70 years
- Diagnosis of scleroderma
- Symptomatic Raynaud’s phenomena and impaired hand function despite treatment with medications
If you think you (or someone you know) may be eligible for the STAR clinical trial, please contact the study coordinator at the most conveniently located study center.
The STAR Clinical Trial Design
The study is a randomized, double-blind study which means that the choice of which investigational treatment (ADRCs or placebo) the patient receives will be made randomly (like tossing a coin) and neither the patient nor the study doctor will know which investigational treatment the patient received. Of the 80 patients to be enrolled, about 40 will receive their own ADRCs and about 40 will receive placebo. When all 80 patients have completed their final visit, those patients who had received placebo and continue to qualify for the study, will be able to receive ADRCs.
The clinical trial will involve the collection of adipose (fat) tissue, using liposuction, from the patient’s body, the preparation of ADRCs from that fat as well as preparation of the placebo, and the subsequent injection of the patient’s own ADRCs (or placebo) into each finger. For more details on the procedure click here.
The study is designed to test whether ADRCs will improve hand function and reduce symptoms of Raynaud’s phenomena. After the injection procedure, patients will be seen in the clinic for follow-up visits six times over approximately 1 year. Prior to the procedure and at these follow-up visits, hand function and Raynaud’s phenemona will be assessed through questionnaires. In addition, hand function will be measured through simple tests of hand strength, mobility, and swelling.
Are there any risks with being in the STAR clinical trial?
The ADRCs, prepared using the investigational Celution® Device, that will be studied in the STAR clinical trial have not been studied enough yet to know whether the treatment provides benefits to patients with impaired hand function from scleroderma. The information gathered during the STAR clinical trial will give doctors and scientists a better idea about whether there might be a benefit.
There are both known and unknown risks associated with the liposuction procedure, the finger injections procedure, and the use of investigational Celution® prepared ADRCs. The study doctor will discuss all of these risks with any patient interested in participating in the clinical trial.
You can learn more about the STAR trial at clinicaltrials.gov
You can learn more about participating in clinical trials at: