Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosis

Phase 2

Recruiting

Conditions: scleroderma
Systemic scleroderma
10003816

Registration Number: NL-OMON47582

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the toxicity of the treatment at 12 weeks after MSC<br /><br>administration, defined as<br /><br>- Local toxicity, including signs of local inflammation (swelling, warmth,<br /><br>impairment of function), worsening of ulcers or new ulcers or hematomes after<br /><br>MSC administration<br /><br>- 2. Other adverse events, graded according to the Common Terminology Criteria<br /><br>for Adverse Events.t.</p><br>

Secondary Outcome Measures