Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)



Status:Completed
Conditions:Skin and Soft Tissue Infections, Cardiology, Neurology, Dermatology, Dermatology
Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - 70
Updated:6/6/2018
Start Date:May 15, 2015
End Date:May 22, 2018

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Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover

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.

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.

Key Inclusion Criteria:

1. Males or females ≥ 18 and ≤ 70 years of age

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

Key Exclusion Criteria:

1. Body Mass Index < 18 kg/m2

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
We found this trial at
19
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Grand Rapids, Michigan 49546
Principal Investigator: R Martin, M.D.
Phone: 616-459-8088
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Laura Hummers, M.D.
Phone: 410-550-8582
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Soumya Chatterjee, M.D.
Phone: 216-444-3290
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Houston, Texas 77030
Principal Investigator: Maureen Mayes, M.D.
Phone: 713-500-7118
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Robyn Domsic, M.D.
Phone: 412-648-7040
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Principal Investigator: Sadi Shahouri, M.D.
Phone: 316-689-6609
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Principal Investigator: Robert Simms, M.D.
Phone: 617-414-2509
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: John Varga, M.D.
Phone: 312-503-2338
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Ankoor Shah, M.D.
Phone: 919-684-6150
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Kansas City, Missouri 64114
Principal Investigator: John Ervin, M.D.
Phone: 816-943-0770
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Lexington, Kentucky 40509
Principal Investigator: Mark Adams, M.D.
Phone: 859-977-7144
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Little Rock, Arkansas 72205
Principal Investigator: John Yocum, M.D.
Phone: 501-224-1348
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Los Angeles, California 90045
Principal Investigator: Daniel Furst, M.D.
Phone: 310-297-6812
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Los Angeles, California 90095
Principal Investigator: Suzanne Kafaja, M.D.
Phone: 310-825-4744
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New Brunswick, New Jersey 08901
Principal Investigator: Vivien Hsu, M.D.
Phone: 732-418-8478
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Robert Spiera, M.D.
Phone: 212-774-2123
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Chris Derk, M.D.
Phone: 215-615-0773
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85037
Principal Investigator: Paul Caldron, D.O.
Phone: 480-626-6656
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Virginia Steen, M.D.
Phone: 202-444-6211
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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