NL-OMON47582
Recruiting
Phase 2
Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosis - MANUS Trial
niversitair Medisch Centrum Utrecht0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- scleroderma
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
- •\*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
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
- •\- Follow\-up impossible
Outcomes
Primary Outcomes
Not specified
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