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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-10-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PB-MNC therapy
The patientsin PB-MNC therapy group will be injected with G-CSF mobilized PB-MNC into calf or thigh muscle of ischemic limb and Aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.
PB-MNC therapy
The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and wound care and pain killer drug
No PB-MNC therapy
In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.
No-PB-MNC therapy
Patients will receive ASA 81 mg once daily and wound care and pain killer drug
Interventions
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PB-MNC therapy
The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and wound care and pain killer drug
No-PB-MNC therapy
Patients will receive ASA 81 mg once daily and wound care and pain killer drug
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe valvular heart disease
* After organ transplantation
* Cardiomyopthy( EF\< 25%)
* Liver failure
* Coagulopathy
* HIV
18 Years
80 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
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Nuttawut Sermsathanasawadi, MD., Ph.D
Role: primary
Other Identifiers
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SI016033012/2
Identifier Type: -
Identifier Source: org_study_id