Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials
The ONE Study showed that infusing patients' own regulatory immune cells after a living-donor kidney transplant is safe, allows lower doses of standard anti-rejection drugs, and is linked to fewer infections without raising rejection in the first year.
Background
Lifelong general immunosuppression after kidney transplantation carries cumulative toxicity and infection risk. The ONE Study tested whether cell-based medicinal products containing regulatory T cells, dendritic cells, or macrophages could safely allow less immunosuppression.
Study design
Seven investigator-led trials at eight hospitals in France, Germany, Italy, the UK, and the USA: a standard-of-care reference group (n=66) and six pooled single-arm cell-therapy trials (n=38) in living-donor kidney transplant recipients, with 60-week follow-up and biopsy-confirmed acute rejection as the primary endpoint.
Key findings
Biopsy-confirmed acute rejection was 12% in the reference group and 16% across the cell-therapy trials. Fifteen of 38 cell-therapy patients (40%) were successfully weaned to tacrolimus monotherapy. Fewer infections were registered in the cell-therapy trials than with standard care.
Safety
Combined adverse event and rejection data revealed no safety concerns versus standard care, and cell therapy was associated with fewer infectious complications, supporting immune cell therapy as a strategy to minimize the burden of general immunosuppression.
Category
Transplant
Source
The Lancet
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