Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Mahidol University
Updated on 14 February 2022
arterial occlusive disease
g-csf
intermittent claudication

Summary

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. 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

Description

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. 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. Pain free walking distance will be evaluated at the day of randomization, 1 , 3, 6 and 12 months by pedometer.

Details
Condition Intermittent Claudication, PAD, Atherosclerotic Ischemic Disease
Treatment PB-MNC therapy, No PB-MNC therapy
Clinical Study IdentifierNCT03683628
SponsorMahidol University
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with chronic arterial occlusive disease who presented with intermittent claudication

Exclusion Criteria

Recent myocardial infarction
Severe valvular heart disease
After organ transplantation
Cardiomyopthy( EF< 25%)
Liver failure
Coagulopathy
HIV
Pregnancy
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