drugset / Trial / NCT02474199
Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction
Phase 1/2
Completed
15 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation in Children · collabRho Federal Systems Division, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This research study is for liver transplant recipients and their respective living donors. The purpose of this study is: 1. To see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells (Tregs) 2. To see if the Tregs allows a liver recipient to take less, or completely stop medications normally taken after receiving an organ transplant.
Timeline
- Start
- 2016-06-06
- Primary completion
- 2019-12-16
- Completion
- 2019-12-16
Publications
- Tang Q, Leung J, Peng Y, Sanchez-Fueyo A, Lozano JJ, Lam A, Lee K, Greenland JR, Hellerstein M, Fitch M, Li KW, Esensten JH, Putnam AL, Lares A, Nguyen V, Liu W, Bridges ND, Odim J, Demetris AJ, Levitsky J, Taner T, Feng S. Selective decrease of donor-reactive Tregs after liver transplantation limits Treg therapy for promoting allograft tolerance in humans. Sci Transl Med. 2022 Nov 2;14(669):eabo2628. doi: 10.1126/scitranslmed.abo2628. Epub 2022 Nov 2.
- Wood-Trageser MA, Lesniak D, Gambella A, Golnoski K, Feng S, Bucuvalas J, Sanchez-Fueyo A, Demetris AJ. Next-generation pathology detection of T cell-antigen-presenting cell immune synapses in human liver allografts. Hepatology. 2023 Feb 1;77(2):355-366. doi: 10.1002/hep.32666. Epub 2022 Aug 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | darTregs | Cell therapy | 4e+08 cells | Intravenous |
| Background | Acetaminophen | Small molecule | 15 mg/kg | — |
| Background | Diphenhydramine | Unknown | 1 mg/kg | — |
| Background | Diphenhydramine | Unknown | 2 mg/kg | — |
Indications
No indication recorded.