NL-OMON37216
Not yet recruiting
Phase 3
Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia A double blind placebo controlled study in diabetic and non-diabetic patients - Autologous bone marrow for peripheral artery disease.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- claudication
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with persistent (\>3 months, despite optimal treatment) disabling claudication or with critical leg ischemia (Fontaine's stages IIb\-IV or Rutherford's categories 3\-6\) without adequate options for improvements by PTA or reconstructive surgery will be included in the study.
Exclusion Criteria
- •candidates for angioplasty or bypass procedures
- •\-inability to undergo bone marrow harvesting
- •\-any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM\-MNC treatment
Outcomes
Primary Outcomes
Not specified
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