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

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

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

Study Overview

• Status: Recruiting
• Conditions: Intermittent Claudication; Atherosclerotic Ischemic Disease; PAD
• Intervention / Treatment: Procedure: PB-MNC therapy; Drug: No PB-MNC therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuttawut Sermsathanasawadi, MD, PhD; Phone Number: +6624198021; Email: nuttawut@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Faculty of medicine, Siriraj hospital, Mahidol university
      • Contact: Nuttawut SERMSATHANASAWADI; Phone Number: +6624198021; Email: nuttawut@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	Drug: No PB-MNC therapy; Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain free walking distance	the maximum distance which patient could walk without pain	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Transcutaneous oxygen measurement (TCOM)	Transcutaneous oxygen measurement	1,3,6,12 month
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
Pain free walking distance	the maximum distance which patient could walk without pain	1,6,12 month

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Nuttawut SERMSATHANASAWADI, MD, PhD, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 22, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication
• Other Study ID Numbers: SI016033012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No