Table 1.
Completed clinical studies using T-regs.
| Study | Organ | Recipients | Dosage | Graft survival | Rejection | Phase | Study outcome | |
|---|---|---|---|---|---|---|---|---|
| Applicability, Safety, and Biological Activity of Regulatory T Cell Therapy in Liver Transplantation (11) | Liver | 9 | A) Pre transplantation: 0.5-1 x 106 Tregs/kg (3 participants) | 100% | 0% | I | T-reg infusions are safe and tolerable for liver transplant patients. | |
| B) Three months after transplantation: 3-4.5 x 106 Tregs/kg (6 participants) | ||||||||
| A pilot study of operational tolerance with a regulatory T- cell based cell therapy in living donor liver transplantation (12) | Liver | 10 | T cells 3.39 ± 106 /kg | 100% | 33.33% | I/IIA | Seven patients successfully discontinued the use of immunosuppressive agents. Three remaining participants developed mild rejection and resumed low-dose immunotherapy. | |
| A Phase I Clinical Trial with Ex Vivo Expanded Recipient Regulatory T cells in Living Donor Kidney Transplants (13) | Kidney | 9 | A) 0.5 x 109 Treg cells/recipient | 100% | 0% | I | Infusion is safe for use and studies should advance to phase II trials. | |
| B) 1 x 109 Treg cells/recipient | ||||||||
| C) 5 x 109 Treg cells/recipient | ||||||||
| Polyclonal Treg Adoptive Therapy for Control of Subclinical Kidney Transplant Inflammation (TASKp trial) (14) | Kidney | 3 | 320x106 cells | 100% | 0% | I | Treg infusions were safe and were not associated with side effects or acute rejections. In addition, the Treg infusions showed a decrease in expression of inflammatory genes in 2 out of three of the patients | |
| Feasibility, Long-term Safety and Immune Monitoring of Regulatory T Cell Therapy in Living Donor Kidney Transplant Recipient (15) | Kidney | 12 | A) 1×106 kg/cells | 100% | 0% | I | Demonstrated the feasibility and safety of Treg use in solid organ transplantation and the need for future trials on investigating efficacy. | |
| B) 3×106 kg/cells | ||||||||
| C) 6×106 kg/cells | ||||||||
| D) 10×106 kg/cells | ||||||||
| Regulatory T cells for minimising immune suppression in kidney transplantation: phase I/IIa clinical trial (16) | Kidney | 11 | nTreg | 100% | 0 | I/IIa | Demonstrated the use of autologous nTregs was safe and feasible even in patients who had a kidney transplant and were immunosuppressed | |
| A) 0.5 x106 fresh cells/kg | ||||||||
| B) 1.0 x 106 fresh cells/kg | ||||||||
| C) 2.5-3.0 ×106 fresh cells/kg | ||||||||
| A Clinical Trial With Adoptive Transfer of Ex Vivo-induced, Donor-specific Immune-regulatory Cells in Kidney Transplantation-A Second Report (17) | Kidney | 16 | total number of infused cells: 14.3 - 35.7 × 106 /kg BW | 50% | 50% | I/IIa | Autologous T reg infusion may induce alloimmune hyporesponsiveness, but complete cessation of immunosuppressive therapies could not be achieved and requires more study | |
| 0.21 to 2.9 × 106 /kg BW of CD4+CD25+Foxp3+ cells | ||||||||