Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
STAR
1 other identifier
interventional
88
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Typical duration for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedStudy Start
First participant enrolled
May 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2018
CompletedJune 4, 2018
June 1, 2018
2.4 years
March 12, 2015
June 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cochin score
24 Weeks
Secondary Outcomes (3)
Cochin score
48 Weeks
Raynaud's Condition Score
24 Weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
24 Weeks
Other Outcomes (12)
Cochin Score
up to 48 Weeks
Raynaud's Condition Score
up to 48 Weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
up to 48 Weeks
- +9 more other outcomes
Study Arms (2)
Adipose Derived Regenerative Cells
EXPERIMENTALAdipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs administered in 2 injections per digit on both hands.
Placebo
PLACEBO COMPARATORSterile 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.
Interventions
ADRCs prepared using the investigational Celution Device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85253, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Arthritis Associates of Southern California
Los Angeles, California, 90045, United States
UCLA David Geffen School of Medicine
Los Angeles, California, 90095, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Northwestern University
Chicago, Illinois, 60611, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
West Michigan Rheumatology, PLLC
Grand Rapids, Michigan, 49546, United States
Center For Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
University of Texas Houston Medical School
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 35358372DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Kesten, MD
Cytori Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 24, 2015
Study Start
May 15, 2015
Primary Completion
September 19, 2017
Study Completion
May 22, 2018
Last Updated
June 4, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share