Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
Phase 1
- Conditions
- Ischemia
- Registration Number
- NCT00442143
- Lead Sponsor
- Odense University Hospital
- Brief Summary
The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization
- Detailed Description
10 patients with severe lower limb ischemia will be included in this pilote trial.
Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.
The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Ankle blood pressure < 70 mmgHG
- Either pain at rest and/or ischemic wound
- No possible surgical treatment
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Exclusion Criteria
- Infection
- Malignant disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Transcutaneous oxygen pressure 1st toe blood pressure (strain gauge) Ankle blood pressure Wound healing Pain
- Secondary Outcome Measures
Name Time Method amputation Infection
Trial Locations
- Locations (1)
Department of endocrinology M, Odense University Hospital
🇩🇰Odense, Denmark