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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03683628
• Other study ID #: SI016033012
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Mahidol University
• Contact: Nuttawut Sermsathanasawadi, MD, PhD
• Phone: +6624198021
• Email: nuttawut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerotic Ischemic Disease
• Intermittent Claudication
• PAD

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain free walking distance	the maximum distance which patient could walk without pain	3 month
Secondary	Ankle brachial index (ABI)	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)	1,3,6,12 month
Secondary	Toe brachial index (TBI)	Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures	1,3,6,12 month
Secondary	Transcutaneous oxygen measurement (TCOM)	Transcutaneous oxygen measurement	1,3,6,12 month
Secondary	36-Item Short Form Health Survey (SF36)	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.	1,3,6,12 month
Secondary	Pain free walking distance	the maximum distance which patient could walk without pain	1,6,12 month