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

NCT03683628 | Unknown

• 1 other identifier: SI016033012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Intermittent Claudication; PAD; Atherosclerotic Ischemic Disease

Outcome Measures

Primary Outcomes (1)

• Pain free walking distance

  the maximum distance which patient could walk without pain

  3 month

Secondary Outcomes (5)

• Ankle brachial index (ABI)

  1,3,6,12 month

• Toe brachial index (TBI)

  1,3,6,12 month

• Transcutaneous oxygen measurement (TCOM)

  1,3,6,12 month

• 36-Item Short Form Health Survey (SF36)

  1,3,6,12 month

• Pain free walking distance

  1,6,12 month

Study Arms (2)

PB-MNC therapy

ACTIVE COMPARATOR

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.

Procedure: PB-MNC therapy

No PB-MNC therapy

ACTIVE COMPARATOR

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.

Drug: No PB-MNC therapy

Interventions

PB-MNC therapy 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

PB-MNC therapy

No PB-MNC therapy DRUG

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

No PB-MNC therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuttawut SERMSATHANASAWADI, MD, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuttawut Sermsathanasawadi, MD, PhD

CONTACT

+6624198021; nuttawut@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor who measure the pain free walking distance, ABI, TBI,TCOM do not know the result of randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 25, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)