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Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

NCT04356755 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-31

No results posted yet for this study

Summary

Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.

Conditions

Interventions

DRUG

AdMSC

At day 0, patients will have AdMSC injections in their ischemic DU. Patients will be followed-up for 16 weeks

DRUG

Placebo

At day 0, patients will have placebo injections in their ischemic DU. Patients will be followed-up for 16 weeks

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Grégory PUGNET, MD, PHD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT04356755 on ClinicalTrials.gov