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Clinical Trials/NL-OMON45407
NL-OMON45407
Withdrawn
Phase 2

Allogeneic mesenchymal Stromal cells for Angiogenesis and neovascularization in no-option Ischemic Limbs - SAIL Trial

niversitair Medisch Centrum Utrecht0 sites60 target enrollmentTBD
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ConditionsPAOD Fontaine 3-4Severe Limb Ischemia (SLI)10003216

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
PAOD Fontaine 3-4
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
60
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\-age \>18 years
  • •\-severe peripheral artery disease (PAD) (Fontaine class III or IV)
  • •(Rutherford 4 or 5\)
  • •\-persistent, recurring rest pain requiring analgesia, and/or non\-healing
  • •ulcers present for \>4 weeks without evidence of improvement in
  • •response to conventional therapies
  • •\-ankle brachial index (ABI) \<0\.6 or non\-compressible/ unreliable
  • •\-not eligible for surgical or endovascular revascularization
  • •\-written informed consent.

Exclusion Criteria

  • •\-history of neoplasm or malignancy in the past 10 years
  • •\-serious known concomitant disease with life expectancy \<1 year
  • •\-Rutherford 6 in which amputation on the short term (within 1\-2 weeks)
  • •is inevitable
  • •\-Pregnancy or unwillingness to use birth control measures such as oral
  • •contraceptives or other (hormonal, uterine implant, barrier method)
  • •precautions during study
  • •\-uncontrolled infection with systemic symptoms
  • •\-follow\-up impossible

Outcomes

Primary Outcomes

Not specified

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