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RECRUITING
NCT06174597
EARLY_PHASE1

Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy

Sponsor: Nanjing University

View on ClinicalTrials.gov

Summary

This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia (CLI). During the second perid, it was a single-center, randomized, controlled prospective study to determine the efficacy of the UCA-PSCs treatment. Those who had CLI were enrolled in the study.

Official title: Efficacy and Safety of Umbilical Cord Artery-derived Perivascular Stem Cells in Patients With Critical Limb Ischemia

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-06-30

Completion Date

2026-06-30

Last Updated

2023-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

UCA-PSCs/bFGF or bFGF Intramuscular injection

After skin disinfection, according to the distribution characteristics of blood vessels around the vascular lesion area, the site that is most likely to establish a new collateral circulation in vascular anatomy is selected. According to the vascular lesion of each subject, 40 reasonable injection sites are selected for Clusters of umbilical cord artery-derived perivascular stem cells with bFGF or bFGF only.

Locations (1)

The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China