Scleroderma Treatment With Celution Processed ADRCs Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Scleroderma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No