Actively Recruiting
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Led by UMC Utrecht · Updated on 2025-09-10
20
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of systemic sclerosis according to the 2013 ACR/EULAR criteria
- At least one active painful digital ulcer larger than 2 mm with visible depth that has not improved with intravenous prostacyclins
- Ulcer(s) worsening within 1 month after prostacyclin treatment, or no improvement after 2 months, or recurrence at the same location within 3 months
- Written informed consent
You will not qualify if you...
- Ulcer with underlying calcinosis confirmed by X-ray
- History of cancer or malignancy within the past 10 years
- Pregnancy or unwillingness to use adequate contraception during the study
- Serious concurrent disease with life expectancy less than 1 year
- Uncontrolled high blood pressure
- Uncontrolled acute or chronic infection with systemic symptoms such as fever
- Unable to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
F
Femke van Rhijn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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