ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma (STAR-II)
Primary Purpose
Scleroderma, Diffuse
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ADRCs
Standard Care
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma, Diffuse focused on measuring Hand Dysfunction, Scleroderma, Scleroderma, Diffuse
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ADRC Arm
Standard Care Arm
Arm Description
Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
Subjects in the Standard Care arm will receive standard care and Placebo
Outcomes
Primary Outcome Measures
Cochin Hand Function Score
Cochin Hand Function Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05148598
Brief Title
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
Acronym
STAR-II
Official Title
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paracrine, INC.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Diffuse
Keywords
Hand Dysfunction, Scleroderma, Scleroderma, Diffuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective
Randomized Parallel Group
Placebo-Controlled
Safety and Efficacy Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo is visually indistinguishable from active treatment.
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADRC Arm
Arm Type
Experimental
Arm Description
Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
Arm Title
Standard Care Arm
Arm Type
Placebo Comparator
Arm Description
Subjects in the Standard Care arm will receive standard care and Placebo
Intervention Type
Device
Intervention Name(s)
ADRCs
Intervention Description
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard care
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo visually indistinguishable from ADRCs
Primary Outcome Measure Information:
Title
Cochin Hand Function Score
Description
Cochin Hand Function Score
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be made available.
Learn more about this trial
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
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