drugset / Trial / NCT03686228

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

NCT03686228 ↗

Unknown 40 enrolled Mahidol University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-10-01
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator ASA Unknown 81 mg —