Clinical Trial

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

Study acronym: ADUSE
Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-04-17; most recent amendment 2025-12-23.
Status change: Suspended → Recruiting 2023-11-09
Status change: Recruiting → Suspended 2023-07-27
Status change: Not Yet Recruiting → Recruiting 2020-10-26
Trial Details
NCT Number NCT04356755
Lead Sponsor University Hospital, Toulouse
Conditions Systemic Sclerosis
Enrollment 32 participants
Start Date 2020-09-22
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-31