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Corporate decision
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Cochin score | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cochin score | Days 30 and 180 | |
| Scleroderma Health Assessment Questionnaire (SHAQ) | Days 7, 30, 90 and 180 | |
| Physician and Patient Global Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Kesten | Cytori Therapeutics | Study Chair |
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Days 7, 30, 90 and 180 |
| Raynaud's Condition Score | Days 7, 30, 90 and 180 |
| EQ-5D | Days 7, 30, 90 and 180 |