Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
NCT02396238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2018-06-04
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.
Conditions
- Scleroderma
- Systemic Sclerosis
- Raynaud Phenomena
- Raynaud's Disease
Interventions
- DEVICE
-
Celution Device
ADRCs prepared using the investigational Celution Device
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Cytori Therapeutics
lead INDUSTRY
Principal Investigators
-
Steven Kesten, MD · Cytori Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-15
- Primary Completion
- 2017-09-19
- Completion
- 2018-05-22
Countries
- United States
Study Locations
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