Cell-Free DNA and AMR

Condition

  • Heart transplant


Study Name

Cell-Free DNA and Antibody-Mediated Rejection in a Cohort of Sensitized Heart Transplant Patients (IRB no.41449)


Summary

The purpose of this study is to observe the measurement of donor cell-free DNA in the blood during routine heart biopsy surveillance visits for use as a marker for antibody-mediated rejection (AMR). The body protects itself from infection with the ability to recognize and destroy foreign material (such as bacterial or viral infections). Sometimes, people who receive a heart transplant have antibodies that attack the new heart, causing it to be rejected by their body; this is known as AMR. The antibodies can severely damage or even destroy the transplanted heart.

This study will assess the utility of cell-free DNA in association with gene expression profiling in heart transplant recipients. Measuring the release of DNA from the transplanted heart in the blood has been proposed to provide information on whether a heart transplant recipient is experiencing AMR.

Financial disclosure: Jon Kobashigawa, MD, has a financial relationship with the sponsor of this study as follows:

  • Serves on the advisory board for the sponsor and has received payment from CareDx, Inc. in the form of a travel grant


Eligibility

Inclusion Criteria:

  • At least 18 years old
  • Signed informed consent
  • Must have pre-transplant panel reactive antibody (PRA) greater than or equal to ten percent, or post-transplant PRA greater than or equal to ten percent, or presence of donor-specific antibodies (DSA) at the time of transplant or any post-transplant detection of DSA, or biopsy-proven, antibody-mediated rejection post-transplant

Exclusion Criteria:

  • Patients receiving multiple organs


Principal Investigator

Jon Kobashigawa, MD


Contact

Camille-Elise Rogacion-Labao
Phone: 310-248-7197
Email: rogacionce@csmns.org