RecruitingPhase 1/2

Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Netherlands20 participantsStarted 2021-10-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Toxicity of the treatment

Timeframe: 12 weeks after MSC administration

Trial details

NCT IDNCT03211793

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Femke van Rhijn, MD

0031887557329 f.c.c.brouwer-3@umcutrecht.nl

View on ClinicalTrials.gov More Systemic Sclerosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.