BridgeMD
MANUS trial
EU CTIS ID: 2024-515387-31-00
What this study is testing
To investigate whether in patients with peripheral vascular complications related to SSc, intramuscular allogeneic BM-MSC therapy is feasible, safe and potentially effective
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >18 years
- Established diagnosis of SSc according to criteria of the American College of Rheumatology (2013)
- At least one active digital ulcer (painful area, >2 mm in diameter with visible depth and loss of dermis) refractory to 5 days intravenous prostacyclines
- informed consent
You likely can't join 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
See the full eligibility criteria
- Age >18 years
- Established diagnosis of SSc according to criteria of the American College of Rheumatology (2013)
- At least one active digital ulcer (painful area, >2 mm in diameter with visible depth and loss of dermis) refractory to 5 days intravenous prostacyclines
- informed consent
- 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
- follow-up impossible
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.