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Clinical Trial Summary

To collect evidence of the safety of administering autologous tolerogenic dendritic cells (ATDC) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluationg cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by ATDC therapy can evntually be used to reduce the need for conventional immunosuppression in transplant recipients.


Clinical Trial Description

Decades of immunosuppressive drug development have 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 ONE Study aims to answer the question as whether ATDC treatment, or immunoregulatory cell-based therapy in general, has any place in the clinical management of solid organ transplant recipients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02252055
Study type Interventional
Source Nantes University Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 19, 2015
Completion date November 14, 2018

See also
  Status Clinical Trial Phase
Terminated NCT02085629 - The ONE Study M Reg Trial Phase 1/Phase 2
Recruiting NCT00291863 - Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis Phase 4