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RECRUITING
NCT07693036
PHASE1/PHASE2

hUC-MSC-Exosomes for T2DM - Safety & Efficacy

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to Evaluate the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus.

Official title: An Exploratory Clinical Study Assessing the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-06-05

Completion Date

2028-06-08

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

exosomes treatment group

GoldenExo(NATX) treatment group (n=32) The specific therapeutic dose for the second stage will be evaluated and determined jointly by the investigators and the Safety Monitoring Committee (SMC) after all three dose escalation trials (1×10¹¹, 3×10¹¹, 9×10¹¹ particles) in the first stage.Subjects in both groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses).

OTHER

control group

active-comparator control:(n=16)The control group will receive an equal volume of the same buffer solution without exosomes (.Subjects in this groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses)

Locations (1)

Peking University first Hospital

Beijing, China