NCT06751199

UCMSCs Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

Investigation of Dose Escalation and Dose Expansion Study on the Safety and Efficacy of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim is to Investigate the safety and efficacy of Portal vein infusion Allogeneic Human umbilical cord mesenchymal stem cells combined with Allogeneic islet transplantation for the treatment of diabetes

Detailed description

This is an investigator-initiated trial (IIT). The first part is an open-label, dose-escalation study involving 9 patients between the ages of 18 and 70. The second part is a non-randomized, active comparator-controlled IIT with a parallel design, comparing allogeneic islet transplantation combined with human umbilical cord mesenchymal stem cells (hUCMSCs) to allogeneic islet transplantation alone in patients with 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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	human umbilical cord mesenchymal stem cells	Portal vein infusion human umbilical cord mesenchymal stem cells
DRUG	allogeneic islet	Portal vein infusion of allogeneic islet

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-07-30
• Completion: 2026-12-01
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: China