Treatment of No-option CLI by G-CSF-mobilized PB-MNC
- Conditions
- PADCritical Limb IschemiaAtherosclerotic Ischemic Disease
- Interventions
- Procedure: PB-MNC therapyDrug: No-PB-MNC therapy
- Registration Number
- NCT03686228
- Lead Sponsor
- Mahidol University
- Brief Summary
This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,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 no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. 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. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months
- Recent myocardial infarction
- Severe valvular heart disease
- After organ transplantation
- Cardiomyopthy( EF< 25%)
- Liver failure
- Coagulopathy
- HIV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PB-MNC therapy 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 and Aspirin 81 mg/day and supportive treatment including wound care and pain killer drug. No PB-MNC therapy No-PB-MNC therapy In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.
- Primary Outcome Measures
Name Time Method Amputation free survival 3 month Rate of non amputated limb
- Secondary Outcome Measures
Name Time Method Amputation free survival 1,6,12 month Rate of non amputated limb
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)
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
Transcutaneous oxygen measurement (TCOM) 1,3,6,12 month Transcutaneous oxygen measurement
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.
Trial Locations
- Locations (1)
Vascular Surgery, Siriraj Hospital, Mahidol University
🇹ðŸ‡Bangkoknoi, Bangkok, Thailand