Clinical Trial: Scleroderma Treatment With Celution Processed ADRCs Registry
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational [Patient 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 Summary: 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.
Sponsor: Cytori Therapeutics
Current Primary Outcome: Change in Cochin score [ Time Frame: Day 90 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Cytori Therapeutics
Dates:
Date Received: December 23, 2014
Date Started: April 2015
Date Completion: June 2017
Last Updated: March 15, 2016
Last Verified: March 2016
