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ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

NCT05148598 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2022-09-28

No results posted yet for this study

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

Interventions

DEVICE

ADRCs

Adipose Derived Regenerative Cells (ADRCs) processed with Celution System

OTHER

Standard Care

Standard care

OTHER

Placebo

Placebo visually indistinguishable from ADRCs

Sponsors & Collaborators

  • Paracrine, INC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-12-30
Completion
2025-12-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148598 on ClinicalTrials.gov