Tests injected stem cells for finger sores in systemic sclerosis
Tests injected donor stem cells against placebo in adults with finger sores from systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Key facts
- Where
- Utrecht, NetherlandsSee the site
- Phase
- Phase 1/2
Where in Netherlands
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT03211793EU 2024-515387-31-00
- Record updated
- 10 September 2025
- Original description
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.Read full original descriptionShow less
Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial
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.
Inclusion: 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: Ulcer with underlying calcinosis (ruled out by X-ray prior to screening/inclusion); Serious known concomitant disease with life expectancy <1 year; History of neoplasm or malignancy in the past 10 years; Uncontrolled hypertension; Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever); Pregnancy or unwillingness to use adequate contraception during study; Follow-up impossible.