Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
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
| Condition(s) | Systemic Sclerosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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), * Age \> 50 years and not treated with any kind of hormone replacement therapy for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening. An assessment of serum follicle stimulating hormone showing a level of \> 40 TU/L at screening may be used to exclude childbearing potential, based on the discretion of the investigator, * Patient must have provided written informed consent prior to enrolment, * Patient must be able to understand their requirem |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Toulouse |
| Locations | Grenoble, France; Lille, France; Marseille, France; Montpellier, France; Nantes, France; Poitiers, France (+1 more sites) |
| Start date | 2020-09-22 |
| NCT ID | NCT04356755 |
| Official listing | https://clinicaltrials.gov/study/NCT04356755 |