Table 2.
Future/ongoing clinical trials using T-regs.
| Study | Organ | Recipients | Dosage | Phase | Goal | Status |
|---|---|---|---|---|---|---|
| Treatment of Children with Kidney Transplants by Injection of CD4+CD25+PoxP3+ T cells to Prevent Organ Rejection (24) | Kidney | 30 | 2x108 autologous T regs 1 month and 180 days after transplant | I | To assess the patient and graft survival of those receiving standard immunosuppressive therapy and those receiving Tregs. | Completed 2014. No results posted. |
| Liver Transplantation with Tregs at MGH (25) | Liver | 9 | 2.5 x 106 Tregs | I/II | Exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients | Ongoing |
| A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients (26) | Kidney | 12 | Not stated | n/a | To determine the safety and effectiveness of collecting, expanding and infusing Tregs to kidney transplant patients undergoing immunosuppressive therapy. | Ongoing |
| The ONE study nTreg Trial (ONEnTreg13) (27) | Kidney | 17 | 0.5 x 106, 1 x 106, and 2.5-3 x 106 cells/kg body weight | I/II | Aims to explore the feasibility, safety, efficacy, of regulatory cell therapies using CD4+CD25+FOXP3+ nTregs in the context of living-donor renal transplantation. | Completed November 1, 2017. Awaiting results |
| Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (ARTEMIS) (28) | Liver | 14 | 400x106 darTregs (range 300-500 x106) | I/II | Assess incidences of adverse events associated with darTreg infusion, incidence of infection and malignancy. This study will also measure the number and proportion of individuals who are able to reduce calcineurin inhibitor dosing by 75%. | Completed 2019. Awaiting results |
| Treg Therapy in Subclinical Inflammation in Kidney Transplantation (29) | Kidney | 33 | Single infusion of 550 ± 450 x 106 polyTregs | I/II | The goal of this study is to assess the efficacy of Tregs to reduce graft inflammation. | Ongoing |
| The ONE Study UK Treg Trial (ONETreg1) (30) | Kidney | 15 | 1-10 million cells/kg | I/II | Explore the potential benefits of Treg therapy as an adjunct with immunosuppressive treatment in living donor transplants. | Completed March 3, 2017. Awaiting Results |
| Oxford Two Study (31) | Kidney | Minimum 34 | Not stated | II | Achieve monotherapy with sirolimus and Tregs for kidney transplant patients in order to prove the protective effect of Tregs on kidney transplants. | Ongoing/Recruiting |
| Infusion of T-Regulatory Cells in Kidney Transplant recipients (The ONE Study) (32) | Kidney | 5 | N/A | I | Measure the safety and feasibility of administering Treg cells derived from a patient and administered alongside belatacept. | Completion date: March 2, 2016, Still Awaiting results |
N/A, Not applicable.