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The ONE Study nTreg Trial (ONEnTreg13)

NCT02371434 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-02-05

No results posted yet for this study

Summary

The aim of this trial is to collect evidence of the safety of administering autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant recipients. In addition, the study will determine whether post-transplant nTregs infusion allows a tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.

Conditions

  • Immunosuppressive Treatment of Living-donor Renal Transplantation

Interventions

BIOLOGICAL

autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)

autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs). nTregs will be infused at escalating doses of 0.5 x 10\^6, 1 x 10\^6, and 2.5-3 x 10\^6 cells/kg body weight in cohorts of three patients each.

Sponsors & Collaborators

  • Prof. Dr. Petra Reinke

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-11-01
Completion
2017-11-01

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 NCT02371434 on ClinicalTrials.gov