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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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