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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Mahidol University
Updated on 14 February 2022
granulocyte colony stimulating factor
gangrene
rest pain
ischemic ulcer

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.

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.

Details
Condition PAD, Critical Limb Ischemia, Atherosclerotic Ischemic Disease
Treatment PB-MNC therapy, No-PB-MNC therapy
Clinical Study IdentifierNCT03686228
SponsorMahidol University
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion Criteria

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

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