BH-Pilot 2015 was a clinical study performed during 2015-2016 in “La Paz” and “Puerta de Hierro” University Hospitals (Madrid). The study included 70 patients at least 1 year after the renal transplant (immunosuppression maintenance period). They were classified into three categories depending on their immunological risk evaluation:
- High-risk patients (history of rejection, positive HLA antibodies, impaired renal function, or any combination of the previous criteria)
- Controlled patients (with conventional maintenance immunosuppression)
- Low-risk patients (lack of risk criteria and treated with low levels of IS for years).
Data of patients’ clinical and immunological history were collected; an extensive battery of biomarkers (proteomics, metabolomics and cell phenotyping) was performed to complement the risk information, and 10 ml of blood was taken to be tested with the IMBG
The study outcomes indicated a positive proof of concept for the IMBG that can be summarized in the following points:
1) IMBG provides an individualized patient response pattern to immunosuppressive medication.
2) Sensitivity ranges can be determined in each patient for each of the drugs and doses tested.
3) Significantly associated low-sensitivity patterns to IMSs in IMBG have been observed in patients with high risk-profile who present worse clinical evolution.
4) Patients with a low-risk profile show better sensitivity scores to IS in IMBG compared with standard patients and high-risk patients.
The classification of the immunoassay profiles can be reproduced accurately by a neural network and be completely automatized.
The outcomes of the study indicate that the IMBG enables the measurement of the sensitivity/resistance profile of patients to immunosuppressant medication, and can detect patients with bad prognosis due to IS low sensitivity.