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Scleroderma Treatment With Celution Processed ADRCs Registry (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: NCT02328625
Recruitment Status : Withdrawn (Corporate decision)
First Posted : December 31, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Tracking Information
First Submitted Date December 23, 2014
First Posted Date December 31, 2014
Last Update Posted Date March 17, 2016
Study Start Date April 2015
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2014)
Change in Cochin score [ Time Frame: Day 90 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 23, 2014)
  • Change in Cochin score [ Time Frame: Days 30 and 180 ]
  • Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: Days 7, 30, 90 and 180 ]
  • Physician and Patient Global Assessment [ Time Frame: Days 7, 30, 90 and 180 ]
  • Raynaud's Condition Score [ Time Frame: Days 7, 30, 90 and 180 ]
  • EQ-5D [ Time Frame: Days 7, 30, 90 and 180 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Scleroderma Treatment With Celution Processed ADRCs Registry
Official Title Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry
Brief Summary This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.
Detailed Description This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.
Condition Scleroderma
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Withdrawn
Actual Enrollment
 (submitted: March 15, 2016)
0
Original Estimated Enrollment
 (submitted: December 23, 2014)
500
Estimated Study Completion Date June 2017
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of scleroderma and presence of hand scleroderma
  • Cochin score ≥ 20 units

Exclusion Criteria:

  • Body Mass Index < 17 kg/m2
  • Infection in any finger
  • Stable medications for the treatment of scleroderma for ≥ 1 month
  • Pregnant or lactating status.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02328625
Other Study ID Numbers STAR Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cytori Therapeutics
Study Sponsor Cytori Therapeutics
Collaborators Not Provided
Investigators
Study Chair: Steven Kesten Cytori Therapeutics
PRS Account Cytori Therapeutics
Verification Date March 2016