NCT06407297

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

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

Detailed description

This is an IIT study, where the first part is an open, dose escalating study consisting of 9 patients, 8-18 years of age. The second part is a randomized, double-blinded, placebo-controlled, IIT study in parallel design comparing allogeneic UCMSCs treatment to placebo in pediatric patients diagnosed with newly onset type 1 diabetes. Besides safety, preservation of endogenous insulin production (measured as C-peptide concentrations) together with metabolic control, diabetes treatment satisfaction and immunological profile will be assessed. A total number of 24 patients will be enrolled in the study and followed for one year after UCMSCs/placebo treatment. Patients 8-18 years of age, both male and female, diagnosed for type 1 diabetes will be eligible. Providing informed consent and fulfillment of inclusion criteria and no exclusion criteria, they will within 6 months of diagnosis be randomized.

Conditions

• Newly Diagnosed Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	UCMSCs	Peripheral intravenous infusion of umbilical cord mesenchymal stem cells
DRUG	Placebo	Peripheral intravenous infusion of Placebo

Timeline

• Start date: 2024-05-23
• Primary completion: 2025-09-30
• Completion: 2026-05-01
• First posted: 2024-05-09
• Last updated: 2024-12-27

Locations

1 site across 1 country: China