RecruitingEarly Phase 1NCT06174597

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

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

Sponsor

Nanjing University

Enrollment

40 participants

Start Date

Jun 30, 2023

Study Type

INTERVENTIONAL

Conditions

Critical Limb Ischemia

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called UCA-PSCs/bFGF or bFGF Intramuscular injection for people with critical limb ischemia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUCA-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.