Regulatory T cells for minimising immune suppression in kidney transplantation: phase I/IIa clinical trial.

ABSTRACT:

Objective

To assess whether reshaping of the immune balance by infusion of autologous natural regulatory T cells (nTregs) in patients after kidney transplantation is safe, feasible, and enables the tapering of lifelong high dose immunosuppression, with its limited efficacy, adverse effects, and high direct and indirect costs, along with addressing several key challenges of nTreg treatment, such as easy and robust manufacturing, danger of over immunosuppression, interaction with standard care drugs, and functional stability in an inflammatory environment in a useful proof-of-concept disease model.

Design

Investigator initiated, monocentre, nTreg dose escalation, phase I/IIa clinical trial (ONEnTreg13).

Setting

Charité-University Hospital, Berlin, Germany, within the ON

SUBMITTER: Roemhild A 

PROVIDER: S-EPMC7576328 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature