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Treatment of No-option CLI by G-CSF-mobilized PB-MNC

Not Applicable
Conditions
PAD
Critical Limb Ischemia
Atherosclerotic Ischemic Disease
Interventions
Procedure: PB-MNC therapy
Drug: No-PB-MNC therapy
Registration Number
NCT03686228
Lead Sponsor
Mahidol University
Brief Summary

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months.

Detailed Description

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months
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Exclusion Criteria
  • Recent myocardial infarction
  • Severe valvular heart disease
  • After organ transplantation
  • Cardiomyopthy( EF< 25%)
  • Liver failure
  • Coagulopathy
  • HIV
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PB-MNC therapyPB-MNC therapyThe 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.
No PB-MNC therapyNo-PB-MNC therapyIn patients in No PB-MNC therapy, they will receive aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.
Primary Outcome Measures
NameTimeMethod
Amputation free survival3 month

Rate of non amputated limb

Secondary Outcome Measures
NameTimeMethod
Amputation free survival1,6,12 month

Rate of non amputated limb

Ankle brachial index (ABI)1,3,6,12 month

Ankle brachial indexThe Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD)

Toe brachial index (TBI)1,3,6,12 month

Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures

Transcutaneous oxygen measurement (TCOM)1,3,6,12 month

Transcutaneous oxygen measurement

36-Item Short Form Health Survey (SF36)1,3,6,12 month

SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.

Trial Locations

Locations (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

🇹🇭

Bangkoknoi, Bangkok, Thailand

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