NCT05294822

Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, phase IIT clinical trial to evaluate autologous regenerative islet transplantation for insulin-dependent diabetes mellitus. Twenty patients with insulin-dependent diabetes mellitus will be enrolled: poor blood glucose control despite intensive exogenous insulin therapy. The primary endpoint will be defined by the return to normal blood glucose control without insulin at 12 months after transplantation.

Conditions

• Diabetes

Interventions

Type	Name	Description
PROCEDURE	Autologous regenerative islet transplantation for insulin-dependent diabetes mellitus	Islet transplantation was completed using percutaneous transhepatic portal vein puncture. After transplantation, rabbit anti human thymocyte immunoglobulin (ATG) or basiliximab was used as induction therapy and low-dose tacrolimus combined with sirolimus or mycophenolate mofetil were used as immunosuppressive maintenance therapy.

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2022-03-24
• Last updated: 2022-03-24

Locations

1 site across 1 country: China