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Clinical Trials/EUCTR2015-000168-32-NL
EUCTR2015-000168-32-NL
Active, not recruiting
Phase 1

Mesenchymal stem cells for Angiogenesis and Neovascularization in digital Ulcers of Systemic sclerosis - MANUS Trial

niversity Medical Center Utrecht0 sitesJuly 9, 2015
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Conditionssystemic sclerosisMedDRA version: 18.0Level: PTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
systemic sclerosis
Sponsor
niversity Medical Center Utrecht
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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 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:

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.

Outcomes

Primary Outcomes

Not specified

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