ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

Paracrine, INC.174 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

174

Conditions

Scleroderma, Diffuse

Interventions

ADRCsDEVICE

Adipose Derived Regenerative Cells (ADRCs) processed with Celution System

Standard CareOTHER

Standard care

PlaceboOTHER

Placebo visually indistinguishable from ADRCs

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cochin Hand Function Score

Time frame: 26 weeks

Data from ClinicalTrials.gov

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