Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC
Primary Purpose
Intermittent Claudication, PAD, Atherosclerotic Ischemic Disease
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
PB-MNC therapy
No PB-MNC therapy
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PB-MNC therapy
No PB-MNC therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pain free walking distance
the maximum distance which patient could walk without pain
Secondary Outcome Measures
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)
Toe brachial index (TBI)
Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures
Transcutaneous oxygen measurement (TCOM)
Transcutaneous oxygen measurement
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.
Pain free walking distance
the maximum distance which patient could walk without pain
Full Information
NCT ID
NCT03683628
First Posted
September 3, 2018
Last Updated
December 16, 2021
Sponsor
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT03683628
Brief Title
Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC
Official Title
Treatment of Intermittent Claudication by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, PAD, Atherosclerotic Ischemic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor who measure the pain free walking distance, ABI, TBI,TCOM do not know the result of randomization
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PB-MNC therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No PB-MNC therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PB-MNC therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
No PB-MNC therapy
Intervention Description
Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week
Primary Outcome Measure Information:
Title
Pain free walking distance
Description
the maximum distance which patient could walk without pain
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Ankle brachial index (ABI)
Description
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)
Time Frame
1,3,6,12 month
Title
Toe brachial index (TBI)
Description
Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures
Time Frame
1,3,6,12 month
Title
Transcutaneous oxygen measurement (TCOM)
Description
Transcutaneous oxygen measurement
Time Frame
1,3,6,12 month
Title
36-Item Short Form Health Survey (SF36)
Description
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
Time Frame
1,3,6,12 month
Title
Pain free walking distance
Description
the maximum distance which patient could walk without pain
Time Frame
1,6,12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuttawut Sermsathanasawadi, MD, PhD
Phone
+6624198021
Email
nuttawut@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuttawut SERMSATHANASAWADI, MD, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuttawut SERMSATHANASAWADI
Phone
+6624198021
Email
nuttawut@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC
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