RecruitingNot ApplicableNCT06407297

UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes

Investigation of Dose Escalation and Cohort Expansion Study on the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells(UCMSCs) Combined With Standard Therapy for Newly Diagnosed Type 1 Diabetes


Sponsor

Shanghai Changzheng Hospital

Enrollment

24 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim is to investigate the safety and tolerability of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells in pediatric patients diagnosed with newly onset type 1 diabetes


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether stem cell therapy (using stem cells from umbilical cord tissue) combined with standard treatment can better preserve insulin production in children and teens newly diagnosed with type 1 diabetes. The goal is to protect the remaining insulin-producing cells in the pancreas. **You may be eligible if...** - You are between 8 and 18 years old - You were diagnosed with type 1 diabetes within the past 6 months - You have at least one diabetes-related autoantibody, or have been diagnosed with autoantibody-negative type 1 diabetes - Your pancreas is still producing some insulin (based on lab tests) **You may NOT be eligible if...** - You were diagnosed with type 1 diabetes more than 6 months ago - Your pancreas is no longer producing detectable insulin - You or your guardian do not consent to stem cell therapy Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGUCMSCs

Peripheral intravenous infusion of umbilical cord mesenchymal stem cells

DRUGPlacebo

Peripheral intravenous infusion of Placebo


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06407297