Systemic Sclerosis Clinical Trial
Official title:
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
The STAR Trial is a prospective, randomized, multi-center device trial intended to assess
safety and efficacy of subcutaneous administration of Celution processed ADRCs into fingers
of patients with hand dysfunction due to scleroderma.
Following informed consent and screening evaluations, eligible subjects will undergo
pre-operative testing. Subjects will then undergo fat harvest through small volume
liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to
isolate and concentrate ADRCs for immediate subcutaneous administration under local
anesthesia. Subjects will be randomly assigned to receive ADRCs (40 million cells) or a
visually-matched placebo in a 1:1 ratio. All subjects will receive subcutaneous
administration of test substance (ADRC or placebo) into all fingers of both hands. Following
completion of all 48 week visits and database lock, placebo treated subjects will be offered
treatment with their ADRCs cells should they continue to qualify according to the
inclusion/exclusion criteria and should they wish to be treated with ADRCs and agree to the
fat harvest procedure.
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