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Clinical Trial Summary

The goal of this clinical trial is to learn if patients who have brittle type 1 diabetes receiving an islet transplantation will have better control of their sugars if they also receive one of 2 types of immune cells along with the islet transplant. The participants will receive either their own immune cells, called regulatory T cells, or immune cells from the bone marrow of the islet donor.


Clinical Trial Description

Islet transplantation success remains limited by the immediate loss of islet after transplantation, rejection, and side effect from immunosuppression. Preclinical animal models provide evidence that donor bone marrow cells OR regulatory T cells infused at the time of islet transplantation can improve the survival of islets after transplantation and reduce the need for immunosuppression. The purpose of this study is to evaluate the feasibility and safety of combining an islet transplant with the recipient's Tregs OR deceased donor bone marrow cells in patients with brittle type 1 diabetes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05973734
Study type Interventional
Source Stanford University
Contact Kevin Ly, BS
Phone 650-497-6057
Email kevinly@stanford.edu
Status Not yet recruiting
Phase Phase 1
Start date October 1, 2023
Completion date May 2028

See also
  Status Clinical Trial Phase
Withdrawn NCT01123122 - A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation N/A
Completed NCT00417131 - Imaging of Islet Transplantation With PET and MRT N/A
Completed NCT02627690 - Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
Completed NCT01369082 - Extended Follow-Up After Islet Transplantation in T1D N/A
Terminated NCT00853944 - Effect of Sitagliptin on Graft Function Following Islet Transplantation Phase 3
Completed NCT03427931 - CGM Use in Islet Transplant Recipients N/A
Terminated NCT00409461 - Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts N/A