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

Intermittent Claudication Clinical Trial

Official title: Treatment of Intermittent Claudication by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atherosclerotic Ischemic Disease
• Intermittent Claudication
• PAD

• NCT number: NCT03683628
• Study type: Interventional
• Source: Mahidol University
• Contact: Nuttawut Sermsathanasawadi, MD, PhD
• Phone: +6624198021
• Email: nuttawut@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Completion date: December 31, 2023