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NCT02252055: ONEatDC

The ONE Study ATDC Trial

Completed Phase 1, PHASE2 Last updated 2 January 2019
What this trial tests

Phase 1, PHASE2 trial testing ATDC_Nantes in Renal Failure, End Stage in 11 participants. Completed in 14 November 2018.

Timeline
19 March 2015
Primary endpoint
14 November 2018
14 November 2018

Quick facts

Lead sponsorNantes University Hospital
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment11
Start date19 March 2015
Primary completion14 November 2018
Estimated completion14 November 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Renal Failure, End Stage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials.
    Sawitzki B, Harden PN, Reinke P, Moreau A, et al · · 2020 · cited 341× · PMID 32446407 · DOI 10.1016/s0140-6736(20)30167-7
  2. Therapeutic induction of antigen-specific immune tolerance.
    Kenison JE, Stevens NA, Quintana FJ. · · 2024 · cited 94× · PMID 38086932 · DOI 10.1038/s41577-023-00970-x
  3. Advances and challenges in immunotherapy for solid organ and hematopoietic stem cell transplantation.
    McDonald-Hyman C, Turka LA, Blazar BR. · · 2015 · cited 86× · PMID 25810312 · DOI 10.1126/scitranslmed.aaa6853
  4. Tolerogenic Dendritic Cells in Solid Organ Transplantation: Where Do We Stand?
    Marín E, Cuturi MC, Moreau A. · · 2018 · cited 79× · PMID 29520275 · DOI 10.3389/fimmu.2018.00274
  5. Update on Dendritic Cell-Induced Immunological and Clinical Tolerance.
    Obregon C, Kumar R, Pascual MA, Vassalli G, et al · · 2017 · cited 75× · PMID 29250057 · DOI 10.3389/fimmu.2017.01514
  6. Role of myeloid regulatory cells (MRCs) in maintaining tissue homeostasis and promoting tolerance in autoimmunity, inflammatory disease and transplantation.
    Amodio G, Cichy J, Conde P, Matteoli G, et al · · 2019 · cited 60× · PMID 30357490 · DOI 10.1007/s00262-018-2264-3
  7. Tolerogenic Dendritic Cells as a Promising Antigen-Specific Therapy in the Treatment of Multiple Sclerosis and Neuromyelitis Optica From Preclinical to Clinical Trials.
    Flórez-Grau G, Zubizarreta I, Cabezón R, Villoslada P, et al · · 2018 · cited 58× · PMID 29904379 · DOI 10.3389/fimmu.2018.01169
  8. Regulatory dendritic cells for human organ transplantation.
    Thomson AW, Metes DM, Ezzelarab MB, Raïch-Regué D. · · 2019 · cited 50× · PMID 31130302 · DOI 10.1016/j.trre.2019.05.001

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