Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.
Eligibility Criteria
Inclusion Criteria: * Established diagnosis of SSc according to the 2013 ACR/EULAR criteria * At least one active digital ulcer (painful area, \>2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins * 'Refractory to prostacyclins' is defined as * Worsening of ulcer(s) within 1 month after prostacyclins iv * No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged by the referring physician * Recurrence of exactly the same ulcer(s) (same location) within 3 months after prostacyclins iv * Written informed consent Exclusion Criteria: * Ulcer with underlying calcinosis (ruled out by X-ray prior to screening/inclusion) * History of neoplasm or malignancy in the past 10 years * Pregnancy or unwillingness to use adequate contraception during study * Serious known concomitant disease with life expectancy \<1 year * Uncontrolled hypertension * Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever) * Follow-up impo