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

NCT ID: NCT03683628

Last Updated: 2021-12-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Intermittent Claudication PAD Atherosclerotic Ischemic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessor who measure the pain free walking distance, ABI, TBI,TCOM do not know the result of randomization

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, Aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week.

Group Type ACTIVE_COMPARATOR

PB-MNC therapy

Intervention Type PROCEDURE

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 walking exercise 3 times/ week

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.

Group Type ACTIVE_COMPARATOR

No PB-MNC therapy

Intervention Type DRUG

Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week

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 walking exercise 3 times/ week

Intervention Type PROCEDURE

No PB-MNC therapy

Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuttawut SERMSATHANASAWADI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Nuttawut Sermsathanasawadi, MD, PhD

Role: CONTACT

Phone: +6624198021

Email: [email protected]

Facility Contacts

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Nuttawut SERMSATHANASAWADI

Role: primary

Other Identifiers

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SI016033012

Identifier Type: -

Identifier Source: org_study_id