NCT03211793RecruitingPhase 1/2
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 27 Apr 2017
- Start date
- 6 Oct 2021
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- UMC Utrecht
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT03211793
- EU CT number
- 2024-515387-31-00
- EudraCT number
- 2015-000168-32
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 6 Oct 2021 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ulcer with underlying calcinosis (ruled out by X-ray prior to screening/inclusion)
- Serious known concomitant disease with life expectancy \<1 year
Other illness
- History of neoplasm or malignancy in the past 10 years
- Uncontrolled hypertension
- Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever)
Other
- Pregnancy or unwillingness to use adequate contraception during study
- Follow-up impossible
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.