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

NCT03683628 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-17

No results posted yet for this study

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

Interventions

PROCEDURE

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

DRUG

No PB-MNC therapy

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Nuttawut SERMSATHANASAWADI, MD, PhD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683628 on ClinicalTrials.gov