This technology is a diagnostic screening that utilizes exosomal protein profiling to non-invasively and cheaply determine the risk of heart transplant rejection.
Unmet Need: Simple method of identifying potential heart transplantation rejection risk
Heart transplantation remains the definitive treatment for advanced heart failure. However, allograft transplantations carry the risk of immunological rejection, an unpredictable and dangerous condition. Current methods to assess rejection risk require either an invasive and costly endomyocardial biopsy or an AlloMap blood test that is unable to detect acute antibody-mediated rejection. As such, there is a need for a non-invasive and cost-effective detection method that can assess both cellular and antibody-mediated rejection for improved management of transplant patients.
The Technology: Non-invasive and cost-effective heart transplant rejection diagnostic using exosomal profiling
This technology identifies a panel of biomarkers in serum exosomes that can be used to determine the risk of heart transplant rejection. Exosomes are highly stable and can be used to detect both cellular and antibody-mediated rejection. These biomarkers are readily measured in the blood using established liquid chromatography-mass spectrometry methods, making this technology a noninvasive and economical method for detecting heart transplant rejection risk.
In a study of patients with either acute cellular rejection or antibody-mediated rejection, this technology successfully separated patients with rejection from the control population. This technology also classified those at risk with the type of rejection as well.
Applications:
- Method to assess probability of cardiac allograft rejection
- Diagnostic screening to determine eligible patients for heart transplantation
- Assessment of transplant rejection risk of other organs
- Research tool for studying heart transplant rejection
- Biomarker detection of other cardiac disease states
- Use of biomarkers as potential therapeutic targets
- Predicting allograft success in pre-transplant heart failure patients
Advantages:
- Non-invasive
- Well-established extraction and analysis methods
- Fewer risks and contraindications relative to biopsy
- Earlier detection of rejection
- Exosomal contents are remarkably stable, reducing the risk of sample degradation
- Low-cost compared to traditional invasive diagnostic techniques
Lead Inventor:
P. Christian Schulze, M.D., Ph.D.
Patent Information:
Patent Status
Related Publications:
Kennel PJ, Saha A, Maldonado DA, Givens R, Brunjes DL, Castillero E, Zhang X, Ji R, Yahi A, George I, Mancini DM, Koller A, Fine B, Zorn E, Colombo PC, Tatonetti N, Chen EI, Schulze PC. “Serum exosomal protein profiling for the non-invasive detection of cardiac allograft rejection” J Heart Lung Transplant. 2018 Mar; 37(3): 409-417.
Kennel PJ, Maldonado D, Givens R, Brunjes D, Castillero E, Chen E, George I, Mancini D, Schulze PC. “Serum Exosomal Protein Profiling for the Non-invasive Detection of Cardiac Allograft Rejection” Circulation. 2015 Nov 6; 132: A16438.
Kennel PJ, Givens R, Brunjes D, Chen E, Castillero E, Takayama H, Naka Y, George I, Mancini D, Schulze PC. “Serum-Derived Exosomal Proteome Analysis of Patients With Heart Failure and After Heart Transplantation” J Heart Lung Transplant. 2015 April; 34(4): S301.
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