Scleroderma Treatment With Celution Processed ADRCs Registry

Cytori Therapeutics

Overview

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.

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

Conditions

Scleroderma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Cochin score

Time frame: Day 90

Secondary Outcomes

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

Data from ClinicalTrials.gov

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