BH-Pilot is a clinical study performed in 2015-2016 in “La Paz” and “Puerta de Hierro” University Hospitals (Madrid). The study included 70 renal transplanted patients at least 1 year after the transplant (immunosuppression maintenance period). They were classified into three categories depending on an immunological risk evaluation:
- High-risk patients (with a history of rejection, positive HLA antibodies or impaired renal function, or combinations of the previous criteria)
- Controlled patients (with conventional maintenance immunosuppression)
- Low-risk patients (without risk criteria and with low levels of IMS 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 were taken to be tested with the IMMUNOBIOGRAM®.
The study outcomes indicated a positive proof of concept for the IMMUNOBIOGRAM® that can be summarized in the following points:
1) The IMMUNOBIOGRAM® 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 the IMMUNOBIOGRAM® 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 IMSs in the IMMUNOBIOGRAM® than standard patients and high-risk patients.
The classification of the immunoassay profiles can be reproduced accurately by a neural network and thus completely automatized.
The outcomes of the study indicate that the IMMUNOBIOGRAM® enables to measure the sensitivity/resistance profile of patients to immunosuppressant medication (IMS), and it can detect patients with bad prognosis due to IMS low sensitivity.