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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02085629
Study type Interventional
Source University of Regensburg
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date July 24, 2014
Completion date December 3, 2018

See also
  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