Treatment of No-option CLI by G-CSF-mobilized PB-MNC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerotic Ischemic Disease
- Critical Limb Ischemia
- PAD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03686228
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nuttawut SERMSATHANASAWADI Mahidol University
Get Well Soon