BMJ: Groundbreaking Test! Regulatory T-cell transplantation is expected to overcome immunosuppression of organ transplantation.

Long-term immunosuppression is currently the standard of care for physical organ transplantation.
the long-term effects of allogeneic transplants have not improved over the past two decades, despite advances in the survival of patients and allogeneic transplants.
long-term complications of chronic rejection and chronic immunosuppression (e.g. infections, malignant tumors, cardiovascular disease and pharmacological toxicity associated with failed transplants) remain a problem, prompting people to seek new treatment strategies.
and Andy Roemhild and others published a research paper online in BMJ, the world's top medical journal, entitled "Regulatory T cells for minimising immune suppression in kidneyation: phase I/IIa clinical trial", a single-center, nTreg dose Incremental, I/IIa Phase Clinical Trials (ONEnTreg13), Recipients of Live Supply Kidney Transplants (ONEnTreg13, n s 11) and corresponding reference group trials (ONErgt11-CHA, n s 9).
the intravenous dose of 0.5, 1.0 or 2.5-3.0×10 x 6 cells/kg body weight 7 days after the kidney transplant was given to CD4 and CD25, FoxP3, nTreg intervention, and then the triple immunosuppression was gradually reduced to a low dose of tekmos monotherapy until the 48th week.
major outcome indicators were assessed through comprehensive endpoints in week 60 and followed up for three years.
for all patients, nTreg products with sufficient yield, purity and functionality can be produced from 40-50 mL extrinsic blood in the first two weeks of a kidney transplant.
of the three nTreg dose increment groups had dose-limiting toxicity.
three-year survival rate of allogeneic transplants in nTreg and reference groups was 100%, and clinical and safety indicators were similar.
8 out of 11 patients who accepted nTreg (73%) achieved stable single-drug immunosuppression, while the reference group still used standard double or triple drug immunosuppression (P s 0.002).
, the application of autologntregs is safe and feasible, even in patients with kidney transplants and immunosuppression.
results are worth further evaluating Treg's efficacy and laying the foundation for the development of next-generation nTreg methods for transplantation and any immunopathology.
cell therapy based on natural regulatory T-cells (nTregs) based on thymus sources is expected to continue to reshape adverse immune responses in a variety of medical adaptations.
the goal of conventional immunosuppression is an unwanted effect sub-mechanism, but unfortunately it also has protective pathways such as nTreg control.
, in patients with immunosuppression, the immune balance is still disturbed and chronic immunosuppression is often required.
the need for lifetime high-dose immunosuppression by reshaping the immune balance with nTreg infusions in immunopathological-related diseases.
preclinical studies have shown that nTregs can delay or prevent transplant rejection or graft resistance to host diseases after solid organ transplantation.
, there are still some outstanding issues and obstacles before nTreg is widely used for cell therapy.
-term immunosuppression is currently the standard of care for physical organ transplantation.
the long-term effects of allogeneic transplants have not improved over the past two decades, despite advances in the survival of patients and allogeneic transplants.
long-term complications of chronic rejection and chronic immunosuppression (e.g. infections, malignant tumors, cardiovascular disease and pharmacological toxicity associated with failed transplants) remain a problem, prompting people to seek new treatment strategies.
identified as a key factor in immunostational stability, and is now the main research focus of transplantation.
, despite nTregs' limited clinical experience, a number of Phase I clinical trials have been conducted over the past decade for different Treg treatments.
, however, key knowledge gaps regarding the optimal use of Treg treatment remain, as reflected in good practice (GMP) programmes, dosages and other issues.
the study was single-center, nTreg dose increment, I/IIa phase clinical trial (ONEnTreg13), recipients of live supply kidney transplants (ONEnTreg13, n s 11) and corresponding reference group trials (ONErgt11-CHA, n s 9).
the intravenous dose of 0.5, 1.0 or 2.5-3.0×10 x 6 cells/kg body weight 7 days after the kidney transplant was given to CD4 and CD25, FoxP3, nTreg intervention, and then the triple immunosuppression was gradually reduced to a low dose of tekmos monotherapy until the 48th week.
major outcome indicators were assessed through comprehensive endpoints in week 60 and followed up for three years.
for all patients, nTreg products with sufficient yield, purity and functionality can be produced from 40-50 mL extrinsic blood in the first two weeks of a kidney transplant.
of the three nTreg dose increment groups had dose-limiting toxicity.
three-year survival rate of allogeneic transplants in nTreg and reference groups was 100%, and clinical and safety indicators were similar.
8 out of 11 patients who accepted nTreg (73%) achieved stable single-drug immunosuppression, while the reference group still used standard double or triple drug immunosuppression (P s 0.002).
, the application of autologntregs is safe and feasible, even in patients with kidney transplants and immunosuppression.
results are worth further evaluating Treg's efficacy and laying the foundation for the development of next-generation nTreg methods for transplantation and any immunopathology.
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