Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03686228
Study type Interventional
Source Mahidol University
Contact Nuttawut SERMSATHANASAWADI
Phone +66851118278
Email nuttawut@gmail.com
Status Recruiting
Phase N/A
Start date October 1, 2018
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03668353 - Recombinant SeV-hFGF2/dF Injection for PAOD Phase 1
Recruiting NCT04110964 - Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT Phase 1
Not yet recruiting NCT03994666 - Cell Therapy in Critical Limb Ischemia Phase 2
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Not yet recruiting NCT02498080 - Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia N/A
Recruiting NCT02239419 - Evaluation of Carbothera in the Treatment of Foot Ulcers N/A
Recruiting NCT01938872 - Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia N/A
Active, not recruiting NCT01211925 - Distal Venous Arterialisation of Ischemic Limb Phase 2/Phase 3
Completed NCT02454231 - Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA) Phase 2/Phase 3
Completed NCT01758874 - Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia Phase 2
Completed NCT02475200 - Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Recruiting NCT04583436 - Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia N/A
Completed NCT04071782 - Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore N/A
Completed NCT03669458 - Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. N/A
Not yet recruiting NCT06007469 - Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
Recruiting NCT04110327 - An All-Comers Observational Study of the MicroStentâ„¢ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Completed NCT02260622 - Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia Phase 2
Recruiting NCT02054416 - External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality N/A