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NCT05148598 Clinical Trial

ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

Scleroderma, Diffuse Clinical Trial

— STAR-II  

Official title:
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05148598
Other study ID # STAR-II, 2021-03.V1
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 28, 2023
Est. completion date December 30, 2025

Study information
Verified date December 2021
Source Paracrine, INC.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 174
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria: - Diffuse cutaneous scleroderma (duration > 5 years) - Cochin Hand Function Scale = 20 units - Symptoms consistent with Raynaud's Phenomenon - Ability to safely undergo liposuction Key Exclusion Criteria: - Active infection - Contracture(s) of any finger - Sympathectomy within 6 months of Screening Visit - Rheumatoid Arthritis

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ADRCs
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
Other:
• Standard Care
Standard care
• Placebo
Placebo visually indistinguishable from ADRCs

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Paracrine, INC.

Outcome
Type Measure Description Time frame Safety issue
Primary Cochin Hand Function Score Cochin Hand Function Score 26 weeks
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