Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
- Conditions
- SclerodermaSystemic SclerosisRaynaud PhenomenaRaynaud's Disease
- Interventions
- Other: PlaceboDevice: Celution Device
- Registration Number
- NCT02396238
- Lead Sponsor
- Cytori Therapeutics
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- Males or females ≥ 18 and ≤ 70 years of age
- Diagnosis of diffuse cutaneous scleroderma (duration > 5 years) or limited cutaneous scleroderma.
- Cochin score ≥ 20 units
- Ability to safely undergo liposuction
- Symptoms consistent with Raynaud's Phemomena
- Compliant with standard preventative recommendations
Key
- Body Mass Index < 18 kg/m2
- Active infection in any finger during screening period or infection in any finger requiring antibiotics in the 30 days prior to the Screening Visit
- Active infection at the potential site(s) of fat harvest during the screening period
- Contractures of any finger or ulceration at point of injection precluding completion of injection procedure
- Amputation of any finger proximal to the proximal interphalangeal joint or any amputation in more than one finger
- Diagnosis of Rheumatoid Arthritis
- Inflammatory arthritis of the hand, including significant osteoarthritis, that is not due to scleroderma or significant acute inflammation in the hand that is due to scleroderma, as per the investigator's clinical judgment
- Oral cyclophosphamide exceeding 2 mg/kg/day, any intravenous cyclophosphamide, methotrexate exceeding 25 mg/week, mycophenolate mofetil exceeding 3 gm/day, hydoxychloroquine exceeding 7 mg/kg/day or azathioprine exceeding 300 mg/day or any other immunosuppressive medication in the 90 days prior to the Screening Visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Sterile Lactated Ringers Solution mixed with small amount of study subject's own freshly drawn blood and administered in 2 injections per digit on both hands. Adipose Derived Regenerative Cells Celution Device Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs administered in 2 injections per digit on both hands.
- Primary Outcome Measures
Name Time Method Cochin score 24 Weeks
- Secondary Outcome Measures
Name Time Method Cochin score 48 Weeks Raynaud's Condition Score 24 Weeks Scleroderma Health Assessment Questionnaire (SHAQ) 24 Weeks
Trial Locations
- Locations (19)
UCLA David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Center For Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Arthritis Associates of Southern California
🇺🇸Los Angeles, California, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Houston Medical School
🇺🇸Houston, Texas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Arizona Arthritis and Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
West Michigan Rheumatology, PLLC
🇺🇸Grand Rapids, Michigan, United States