ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
Phase 3
Not yet recruiting
- Conditions
- Scleroderma, Diffuse
- Interventions
- Device: ADRCsOther: Standard CareOther: Placebo
- Registration Number
- NCT05148598
- Lead Sponsor
- Paracrine, INC.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 174
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADRC Arm Standard Care Subjects in the ADRC arm will receive standard care and active treatment (ADRCs) Standard Care Arm Standard Care Subjects in the Standard Care arm will receive standard care and Placebo Standard Care Arm Placebo Subjects in the Standard Care arm will receive standard care and Placebo ADRC Arm ADRCs Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
- Primary Outcome Measures
Name Time Method Cochin Hand Function Score 26 weeks Cochin Hand Function Score
- Secondary Outcome Measures
Name Time Method