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

Not Applicable

• Conditions: Intermittent Claudication; Atherosclerotic Ischemic Disease; PAD
• Interventions: Drug: No PB-MNC therapy; Procedure: PB-MNC therapy

• Registration Number: NCT03683628
• 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 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-22
• Study First Posted: 2018-09-25
• Study Start: 2018-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with chronic arterial occlusive disease who presented with intermittent claudication

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No PB-MNC therapy	No PB-MNC therapy	In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week.
PB-MNC therapy	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, Aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week.

Primary Outcome Measures

Name	Time	Method
Pain free walking distance	3 month	the maximum distance which patient could walk without pain

Secondary Outcome Measures

Name	Time	Method
Transcutaneous oxygen measurement (TCOM)	1,3,6,12 month	Transcutaneous oxygen measurement
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
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.
Pain free walking distance	1,6,12 month	the maximum distance which patient could walk without pain

Trial Locations

Locations (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand