ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial

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 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.

Key Inclusion Criteria:

• Diffuse cutaneous scleroderma (duration > 5 years)
• Cochin Hand Function Scale ≥ 20 units
• Symptoms consistent with Raynaud's Phenomenon
• Ability to safely undergo liposuction

Key Exclusion Criteria:

• Active infection
• Contracture(s) of any finger
• Sympathectomy within 6 months of Screening Visit
• Rheumatoid Arthritis