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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02396238
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Scleroderma Systemic Sclerosis Raynaud Phenomena Raynaud's Disease Device: Celution Device Other: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover
Actual Study Start Date : May 15, 2015
Actual Primary Completion Date : September 19, 2017
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Celution Device
ADRCs prepared using the investigational Celution Device
Placebo Comparator: 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.
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Cochin score [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Cochin score [ Time Frame: 48 Weeks ]
  2. Raynaud's Condition Score [ Time Frame: 24 Weeks ]
  3. Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: 24 Weeks ]

Other Outcome Measures:
  1. Cochin Score [ Time Frame: up to 48 Weeks ]
  2. Raynaud's Condition Score [ Time Frame: up to 48 Weeks ]
  3. Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: up to 48 Weeks ]
  4. Physician and Patient Global Assessment [ Time Frame: up to 48 Weeks ]
  5. Hand Mobility in Scleroderma (HAMIS) [ Time Frame: up to 48 Weeks ]
  6. Digital ulcer count [ Time Frame: up to 48 Weeks ]
  7. Modified Rodnan Score [ Time Frame: up to 48 Weeks ]
  8. Grip strength and pinch strength [ Time Frame: up to 48 Weeks ]
  9. Finger circumference (with hand volume) [ Time Frame: up to 48 Weeks ]
  10. 1st corner distance and sum of 2nd, 3rd and 4th corner distances [ Time Frame: up to 48 Weeks ]
  11. The EuroQOL five dimensions questionnaire (EQ-5D) [ Time Frame: up to 48 Weeks ]
  12. Adverse events, Serious Adverse Events [ Time Frame: up to 48 Weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396238


Locations
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Sponsors and Collaborators
Cytori Therapeutics
Investigators
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Study Director: Steven Kesten, MD Cytori Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT02396238    
Other Study ID Numbers: STAR Trial
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Livedoid Vasculopathy
 Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Skin Diseases, Vascular