Scleroderma Treatment With Celution Processed ADRCs Registry (STAR)

• ClinicalTrials.gov Identifier: NCT02328625
• Recruitment Status: Withdrawn
• First Posted: December 31, 2014
• Last Update Posted: March 17, 2016
• Sponsor: Cytori Therapeutics
• 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

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

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

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