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
UMC Utrecht
20 participants
Oct 6, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria7
- 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
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Interventions
8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).
8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03211793