NL-OMON47582RecruitingPhase 2
Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosis - MANUS Trial
niversitair Medisch Centrum Utrecht0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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
- •* - 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
- •- Follow-up impossible
Investigators
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