Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
NCT ID: NCT02396238
Last Updated: 2018-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2015-05-15
2018-05-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adipose Derived Regenerative Cells
Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs administered in 2 injections per digit on both hands.
Celution Device
ADRCs prepared using the investigational Celution Device
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.
Placebo
Placebo
Interventions
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Celution Device
ADRCs prepared using the investigational Celution Device
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of diffuse cutaneous scleroderma (duration \> 5 years) or limited cutaneous scleroderma.
3. Cochin score ≥ 20 units
4. Ability to safely undergo liposuction
5. Symptoms consistent with Raynaud's Phemomena
6. Compliant with standard preventative recommendations
Exclusion Criteria
2. Active infection in any finger during screening period or infection in any finger requiring antibiotics in the 30 days prior to the Screening Visit
3. Active infection at the potential site(s) of fat harvest during the screening period
4. Contractures of any finger or ulceration at point of injection precluding completion of injection procedure
5. Amputation of any finger proximal to the proximal interphalangeal joint or any amputation in more than one finger
6. Diagnosis of Rheumatoid Arthritis
7. 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
8. 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
18 Years
70 Years
ALL
No
Sponsors
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Cytori Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Kesten, MD
Role: STUDY_DIRECTOR
Cytori Therapeutics
Locations
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Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Arthritis Associates of Southern California
Los Angeles, California, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Heartland Research Associates
Wichita, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
West Michigan Rheumatology, PLLC
Grand Rapids, Michigan, United States
Center For Pharmaceutical Research
Kansas City, Missouri, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Houston Medical School
Houston, Texas, United States
Countries
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References
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Khanna D, Caldron P, Martin RW, Kafaja S, Spiera R, Shahouri S, Shah A, Hsu V, Ervin J, Simms R, Domsic RT, Steen V, Hummers LK, Derk C, Mayes M, Chatterjee S, Varga J, Kesten S, Fraser JK, Furst DE. Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial. Arthritis Rheumatol. 2022 Aug;74(8):1399-1408. doi: 10.1002/art.42133. Epub 2022 Jun 27.
Other Identifiers
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STAR Trial
Identifier Type: -
Identifier Source: org_study_id
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