Scleroderma Treatment With Celution Processed ADRCs Registry (STAR)

March 15, 2016 updated by: Cytori Therapeutics

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry

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.

Study Overview

Status

Withdrawn

Conditions

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Cochin score
Time Frame: Day 90
Day 90

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytori Therapeutics

Investigators

  • Study Chair: Steven Kesten, Cytori Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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