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Predicting Cellular Rejection With a Cell-Based Assay: Preclinical Evaluation in Children.

Chethan Ashokkumar1, Kyle Soltys, George Mazariegos

  • 11 Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Department of Transplant Surgery, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA. 2 Plexision Inc, Pittsburgh, PA. 3 Tissue Typing Laboratory, Department of Pathology, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA.

Transplantation
|March 8, 2016
PubMed
Summary
This summary is machine-generated.

Allospecific CD154+T-cytotoxic memory cells (CD154+TcM) can predict acute cellular rejection in children undergoing liver or intestine transplants. This biomarker aids in enhancing immunosuppression management and improving clinical outcomes post-transplantation.

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Area of Science:

  • Immunology
  • Transplantation Science
  • Clinical Diagnostics

Background:

  • Allospecific CD154+T-cytotoxic memory cells (CD154+TcM) are potential biomarkers for predicting acute cellular rejection.
  • Previous studies in small cohorts of children showed promise for CD154+TcM in liver and intestine transplantation (LTx/ITx).
  • Clinical implementation and validation were pending for broader application in immunosuppression management.

Purpose of the Study:

  • To establish the safety and probable benefit of using CD154+TcM as a predictive marker for acute cellular rejection.
  • To validate the diagnostic accuracy of CD154+TcM in a larger cohort of pediatric transplant recipients.
  • To standardize the assay for clinical use and assess its reproducibility.

Main Methods:

  • Cryopreserved samples from 214 children (<21 years) were analyzed.
  • A training set (n=158) and an independent validation set (n=122) were used.
  • The immunoreactivity index (IR) was calculated based on recipient CD154+TcM stimulated with donor cells versus HLA non-identical cells.

Main Results:

  • Assay standardization and reproducibility testing showed a mean coefficient of variation <10%.
  • Logistic regression identified distinct pretransplant and posttransplant IR thresholds for rejection prediction.
  • The CD154+TcM assay demonstrated significant sensitivity and specificity in predicting LTx/ITx rejection within 60 days post-sampling.

Conclusions:

  • Allospecific CD154+T-cytotoxic memory cells are validated predictors of acute cellular rejection in pediatric LTx and ITx.
  • The adjunctive use of CD154+TcM testing can enhance clinical outcomes in pediatric transplant recipients.
  • The study establishes safety, with no adverse events reported due to phlebotomy.