Scleroderma Treatment With Celution Processed ADRCs Registry

Withdrawn

• Conditions: Scleroderma

• Registration Number: NCT02328625
• Lead Sponsor: Cytori Therapeutics

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 Timeline

• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-31
• Study Start: 2015-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17
• Primary Completion: 2016-08
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cochin score	Day 90

Secondary Outcome Measures

Name	Time	Method
Change in Cochin score	Days 30 and 180
Scleroderma Health Assessment Questionnaire (SHAQ)	Days 7, 30, 90 and 180
Physician and Patient Global Assessment	Days 7, 30, 90 and 180
Raynaud's Condition Score	Days 7, 30, 90 and 180
EQ-5D	Days 7, 30, 90 and 180