Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mesenchymal stromal cells
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
UMC Utrecht
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov