Mesenchymal stem cells as treatment for non healing wounds on the fingers in patients with systemic sclerosis

Phase 1

• Conditions: systemic sclerosis; MedDRA version: 18.0Level: PTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-000168-32-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-09
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 intravenous prostacyclins
------------‘Refractory to prostacyclins’ is defined as
?-Worsening of ulcer(s) at 1 month after prostacyclins iv
?-No improvement of ulcer(s) at 2 months after prostacyclins iv, as judged by the referring physician
?-Recurrence of exactly the same ulcer(s) (same location) at 3 months after prostacyclins iv
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Ulcer with underlying calcinosis (ruled out by X-ray prior to referral)
-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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determining the safety and efficacy of intramuscularly administered mesenchymal stem cells for the treatment of digital ucers in systemic sclerosis.;Secondary Objective: To assess the accuracy of various parameters related to inflammation, endothelial activation and angiogenesis to predict therapeutic efficacy and/or serve as biomarkers ;Primary end point(s): Number of serious adverse events ;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety: <br>- treatment related toxicity as assessed with the WHO parameters<br><br>Efficacy:<br>-ulcer count, ulcer area<br>-ulcer VAS<br>-quality of life as determined with the S-HAQ, SF-36, EQ5D, CHFS<br>-capillaroscopy semi-quantitative score <br>- change in biomarkers<br>;Timepoint(s) of evaluation of this end point: 12 weeks