drugset / Trial / NCT02932826
Safety Study and Therapeutic Effects of Umbilical Cord Blood Treg on Autoimmune Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells on autoimmune diabetes.
Timeline
- Start
- 2016-10
- Primary completion
- 2025-06
- Completion
- 2025-11
Publications
- Background Milward K, Issa F, Hester J, Figueroa-Tentori D, Madrigal A, Wood KJ. Multiple unit pooled umbilical cord blood is a viable source of therapeutic regulatory T cells. Transplantation. 2013 Jan 15;95(1):85-93. doi: 10.1097/TP.0b013e31827722ed.
- Background Fan H, Yang J, Hao J, Ren Y, Chen L, Li G, Xie R, Yang Y, Gao F, Liu M. Comparative study of regulatory T cells expanded ex vivo from cord blood and adult peripheral blood. Immunology. 2012 Jun;136(2):218-30. doi: 10.1111/j.1365-2567.2012.03573.x.
- Background Brunstein CG, Miller JS, Cao Q, McKenna DH, Hippen KL, Curtsinger J, Defor T, Levine BL, June CH, Rubinstein P, McGlave PB, Blazar BR, Wagner JE. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics. Blood. 2011 Jan 20;117(3):1061-70. doi: 10.1182/blood-2010-07-293795. Epub 2010 Oct 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Umbilical Cord Blood Regulatory T cells Therapy | Unknown | 1e+06 cells/kg | — |
| Subject | Umbilical Cord Blood Regulatory T cells Therapy | Unknown | 5e+06 cells/kg | — |
| Background | Insulin | Protein / enzyme biologic | — | — |