Treatment of No-option CLI by G-CSF-mobilized PB-MNC

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Analgesics

Criteria

Inclusion Criteria:

• Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion Criteria:

• Recent myocardial infarction

• Severe valvular heart disease

• After organ transplantation

• Cardiomyopthy( EF< 25%)

• Liver failure

• Coagulopathy

• HIV