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The ONE Study M Reg Trial

NCT02085629 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

  • Renal Failure, End Stage

Interventions

BIOLOGICAL

Donor M reg (Mreg_UKR)

Experimental: M reg treatment Donor M reg (2.5-7.5 million cells/kg) IV infused (6-7d before Tx) into recipients of a living donor renal Tx. Recipients also receive prednisolone, mycophenolate mofetil and tacrolimus background immunosuppression (as described in detail in the arm description).

Sponsors & Collaborators

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Edward K Geissler, PhD · University Hospital Regensburg, University of Regensburg

  • Bernhard Banas, MD · University Hospital Regensburg, University of Regensburg

  • James A Hutchinson, MD, PhD · University Hospital Regensburg, University of Regensburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-24
Primary Completion
2018-12-03
Completion
2018-12-03

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085629 on ClinicalTrials.gov