Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    CYTORI AND SCLERODERMA

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

Tracking Information
First Submitted Date  ICMJE March 12, 2015
First Posted Date  ICMJE March 24, 2015
Last Update Posted Date June 4, 2018
Actual Study Start Date  ICMJE May 15, 2015
Actual Primary Completion Date September 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Cochin score [ Time Frame: 24 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • Cochin score [ Time Frame: 48 Weeks ]
  • Raynaud's Condition Score [ Time Frame: 24 Weeks ]
  • Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: 24 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 23, 2015)
  • Cochin Score [ Time Frame: up to 48 Weeks ]
  • Raynaud's Condition Score [ Time Frame: up to 48 Weeks ]
  • Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: up to 48 Weeks ]
  • Physician and Patient Global Assessment [ Time Frame: up to 48 Weeks ]
  • Hand Mobility in Scleroderma (HAMIS) [ Time Frame: up to 48 Weeks ]
  • Digital ulcer count [ Time Frame: up to 48 Weeks ]
  • Modified Rodnan Score [ Time Frame: up to 48 Weeks ]
  • Grip strength and pinch strength [ Time Frame: up to 48 Weeks ]
  • Finger circumference (with hand volume) [ Time Frame: up to 48 Weeks ]
  • 1st corner distance and sum of 2nd, 3rd and 4th corner distances [ Time Frame: up to 48 Weeks ]
  • The EuroQOL five dimensions questionnaire (EQ-5D) [ Time Frame: up to 48 Weeks ]
  • Adverse events, Serious Adverse Events [ Time Frame: up to 48 Weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
Official Title  ICMJE Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Scleroderma
  • Systemic Sclerosis
  • Raynaud Phenomena
  • Raynaud's Disease
Intervention  ICMJE
  • Device: Celution Device
    ADRCs prepared using the investigational Celution Device
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2016)
88
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
80
Actual Study Completion Date  ICMJE May 22, 2018
Actual Primary Completion Date September 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02396238
Other Study ID Numbers  ICMJE STAR Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cytori Therapeutics
Study Sponsor  ICMJE Cytori Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Kesten, MD Cytori Therapeutics
PRS Account Cytori Therapeutics
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP