ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

NCT05148598 | Unknown Phase 3 FDA Device

• 1 other identifier: STAR-II, 2021-03.V1
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scleroderma, Diffuse

Keywords

Hand Dysfunction; Scleroderma; Scleroderma, Diffuse

Outcome Measures

Primary Outcomes (1)

• Cochin Hand Function Score

  Cochin Hand Function Score

  26 weeks

Study Arms (2)

ADRC Arm

EXPERIMENTAL

Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)

Device: ADRCs; Other: Standard Care

Standard Care Arm

PLACEBO COMPARATOR

Subjects in the Standard Care arm will receive standard care and Placebo

Other: Standard Care; Other: Placebo

Interventions

ADRCs DEVICE

Adipose Derived Regenerative Cells (ADRCs) processed with Celution System

ADRC Arm

Standard Care OTHER

Standard care

ADRC Arm; Standard Care Arm

Placebo OTHER

Placebo visually indistinguishable from ADRCs

Standard Care Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diffuse cutaneous scleroderma (duration \> 5 years)
• Cochin Hand Function Scale ≥ 20 units
• Symptoms consistent with Raynaud's Phenomenon
• Ability to safely undergo liposuction

You may not qualify if:

• Active infection
• Contracture(s) of any finger
• Sympathectomy within 6 months of Screening Visit
• Rheumatoid Arthritis

Sponsors & Collaborators

• Paracrine, INC.: lead

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo is visually indistinguishable from active treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Prospective * Randomized Parallel Group * Placebo-Controlled * Safety and Efficacy Trial

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 8, 2021
• Study Start: February 28, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: September 28, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share