NCT03686228

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

Status unknown NA Last updated 17 December 2021

What this trial tests

NA trial testing PB-MNC therapy in PAD in 40 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Mahidol University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 October 2018
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Thailand

Drugs / interventions tested

• PB-MNC therapy
• No-PB-MNC therapy

Conditions studied

• PAD — all drugs for PAD →
• Critical Limb Ischemia — all drugs for Critical Limb Ischemia →
• Atherosclerotic Ischemic Disease — all drugs for Atherosclerotic Ischemic Disease →

Sponsor

Mahidol University

Who can join

Adults 18 to 80, any sex, with PAD or Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bioengineering Cell Therapy for Treatment of Peripheral Artery Disease.
   Huang NF, Stern B, Oropeza BP, Zaitseva TS, et al · · 2024 · cited 5× · PMID 38174560 · DOI 10.1161/atvbaha.123.318126