Trials / Unknown
UnknownNCT05148598
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- Sponsor
- Paracrine, INC. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
Detailed description
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ADRCs | Adipose Derived Regenerative Cells (ADRCs) processed with Celution System |
| OTHER | Standard Care | Standard care |
| OTHER | Placebo | Placebo visually indistinguishable from ADRCs |
Timeline
- Start date
- 2023-02-28
- Primary completion
- 2024-12-30
- Completion
- 2025-12-30
- First posted
- 2021-12-08
- Last updated
- 2022-09-28
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05148598. Inclusion in this directory is not an endorsement.