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NOT YET RECRUITING
NCT07769671
PHASE1/PHASE2

Human Umbilical Cord Mesenchymal Stem Cell Infusion for Type 2 Diabetic Nephropathy

Sponsor: The First People's Hospital of Changzhou

View on ClinicalTrials.gov

Summary

Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. This study aims to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN.

Official title: Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection Via Intravenous Infusion in Type 2 Diabetic Nephropathy: A Phase I/IIa Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2026-09-01

Completion Date

2029-08-31

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

Human umbilical cord mesenchymal stem cell injection

Participants will receive intravenous infusions of allogeneic human umbilical cord MSCs in addition to standard treatment. Phase I will evaluate three dose levels (0.5×10\^6/kg, 1.0×10\^6/kg and 2.0×10\^6/kg). Phase IIa will use dose level 1.0×10\^6/kg, subject to adjustment based on Phase I results. Each 6-week treatment cycle will include three infusions administered at 2-week intervals, for a total of three treatment cycles.

Locations (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China