Autologous Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes

Summary

This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 6 months. The study is evaluating whether stem cell transplantation is safe when chemotherapy and immunotherapy are used in combination and if it has immune resetting effect that may halt the immune attack to pancreas islets and thus preserve the body's own insulin production.

Timeline

Start

2008-02

Primary completion

2016-06

Completion

2016-12

Publications

• Background Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76. doi: 10.1001/jama.297.14.1568.
• Ye L, Li L, Wan B, Yang M, Hong J, Gu W, Wang W, Ning G. Immune response after autologous hematopoietic stem cell transplantation in type 1 diabetes mellitus. Stem Cell Res Ther. 2017 Apr 18;8(1):90. doi: 10.1186/s13287-017-0542-1.
• Gu W, Hu J, Wang W, Li L, Tang W, Sun S, Cui W, Ye L, Zhang Y, Hong J, Zhu D, Ning G. Diabetic ketoacidosis at diagnosis influences complete remission after treatment with hematopoietic stem cell transplantation in adolescents with type 1 diabetes. Diabetes Care. 2012 Jul;35(7):1413-9. doi: 10.2337/dc11-2161.
• Zhang X, Ye L, Hu J, Tang W, Liu R, Yang M, Hong J, Wang W, Ning G, Gu W. Acute response of peripheral blood cell to autologous hematopoietic stem cell transplantation in type 1 diabetic patient. PLoS One. 2012;7(2):e31887. doi: 10.1371/journal.pone.0031887. Epub 2012 Feb 22.

Drugs

Indications