Scleroderma Treatment With Celution Processed ADRCs Registry

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.

Full Title of Study: “Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2016

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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Cochin score
    • Time Frame: Day 90

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cytori Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Steven Kesten, Study Chair, Cytori Therapeutics

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