Renal Failure, End Stage Clinical Trial
Official title:
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - M Reg Trial
To collect evidence of the safety of administering donor-derived regulatory macrophage (M reg) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluating cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by M reg therapy can eventually be used to reduce the need for conventional immunosuppression in transplant recipients.
Decades of immunosuppressive drug development has produced an array of powerful
pharmacological agents, but the various drawbacks associated with these treatments leaves
considerable room for improvement. By harnessing the power of suppressive mechanisms in the
human immune system, regulatory cell therapy may be able to support peripheral tolerance and
induce a level of donor-specific unresponsiveness that allows for a reduction in the use of
conventional immunosuppression in organ transplant recipients. Several alternative regulatory
cell types have been identified as potential adjunct immunotherapies for solid organ
transplantation and are now approaching a stage of development that would allow clinical
testing in an early-stage trial. The EU-funded international ONE Study consortium aims to
answer the question as to whether M reg treatment, or other immunoregulatory cell-based
therapies, can be advanced in the clinical management of solid organ transplant recipients.
This particular M reg trial aims to explore the potential of M reg therapy as an adjunct
immunosuppressive treatment in living-donor renal transplant recipients through a clinical
protocol design shared by other investigators in The ONE Study group testing additional
regulatory cell therapies in separate trials.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02252055 -
The ONE Study ATDC Trial
|
Phase 1/Phase 2 | |
Recruiting |
NCT00291863 -
Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis
|
Phase 4 |