Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Systemic Sclerosis, Digital Ulcer

In brief

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.

Key facts

Study ID

NCT03211793

Run by

UMC Utrecht

People needed

20

Starts

2021-10-06

Expected to finish

2026-11-01

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 impossible

Where it is running

• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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