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

• Sponsor: Mahidol University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03683628
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 63
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intermittent Claudication; PAD; Atherosclerotic Ischemic Disease	Procedure: PB-MNC therapy; Drug: No PB-MNC therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The assessor who measure the pain free walking distance, ABI, TBI,TCOM do not know the result of randomization
• Primary Purpose: Treatment
• Official Title: Treatment of Intermittent Claudication by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain free walking distance [3 month]

   the maximum distance which patient could walk without pain

Secondary Outcome Measures

1. Ankle brachial index (ABI) [1,3,6,12 month]

   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)

2. Toe brachial index (TBI) [1,3,6,12 month]

   Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures

3. Transcutaneous oxygen measurement (TCOM) [1,3,6,12 month]

   Transcutaneous oxygen measurement

4. 36-Item Short Form Health Survey (SF36) [1,3,6,12 month]

   SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.

5. Pain free walking distance [1,6,12 month]

   the maximum distance which patient could walk without pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03683628
• Other Study ID Numbers: SI016033012
• First Posted: Sep 25, 2018
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intermittent Claudication

Study Results

No Results Posted as of Dec 17, 2021