ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
NCT ID: NCT05148598
Last Updated: 2022-09-28
Study Results
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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NOT_YET_RECRUITING
PHASE3
174 participants
INTERVENTIONAL
2023-02-28
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Randomized Parallel Group
* Placebo-Controlled
* Safety and Efficacy Trial
TREATMENT
QUADRUPLE
Study Groups
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ADRC Arm
Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
ADRCs
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
Standard Care
Standard care
Standard Care Arm
Subjects in the Standard Care arm will receive standard care and Placebo
Standard Care
Standard care
Placebo
Placebo visually indistinguishable from ADRCs
Interventions
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ADRCs
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
Standard Care
Standard care
Placebo
Placebo visually indistinguishable from ADRCs
Eligibility Criteria
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Inclusion Criteria
* Cochin Hand Function Scale ≥ 20 units
* Symptoms consistent with Raynaud's Phenomenon
* Ability to safely undergo liposuction
Exclusion Criteria
* Contracture(s) of any finger
* Sympathectomy within 6 months of Screening Visit
* Rheumatoid Arthritis
18 Years
70 Years
ALL
No
Sponsors
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Paracrine, INC.
INDUSTRY
Responsible Party
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Other Identifiers
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STAR-II, 2021-03.V1
Identifier Type: -
Identifier Source: org_study_id
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