Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
NCT ID: NCT01833585
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
8 participants
INTERVENTIONAL
2013-04-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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peripheral blood mononuclear cells
peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia
Peripheral blood mononuclear cell
Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia
Interventions
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Peripheral blood mononuclear cell
Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia
Eligibility Criteria
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Inclusion Criteria
* Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
* Poor distal artery runoff
* Age 18-70 year
Exclusion Criteria
* Receive blood component within 4 weeks
* Acute myocardial infarction
* severe valvular heart disease
* renal failure
* liver failure
* Cancer
* Hypercoagulable state
* Severe infection
* Pregnancy
18 Years
70 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Nuttawut Sermsathanasawadi, MD.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Countries
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Other Identifiers
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SIRIRAJR015533013
Identifier Type: -
Identifier Source: org_study_id
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