Scleroderma, Diffuse
Conditions
Keywords
Hand Dysfunction, Scleroderma, Scleroderma, Diffuse
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.
Interventions
DEVICEADRCs
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
OTHERStandard Care
Standard care
OTHERPlacebo
Placebo visually indistinguishable from ADRCs
Sponsors
Paracrine, INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo is visually indistinguishable from active treatment.
Intervention model description
* Prospective * Randomized Parallel Group * Placebo-Controlled * Safety and Efficacy Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cochin Hand Function Score | 26 weeks | Cochin Hand Function Score |
Outcome results
None listed