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

Recruiting Phase 2 Interventional Study
Systemic Sclerosis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
University Hospital, Toulouse · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or female patient ≥18 years of age, * Patient with systemic sclerosis according to the 2013 ACR/EULAR classification criteria9, * SSc patient with at least one refractory active ischemic digital ulcer at "inclusion visit" (see below the eligibility conditions of a DU), * …
Contacts

Grégory PUGNET, MD, PHD

05 61 77 71 26

pugnet.g@chu-toulouse.fr

CONTACT