TRANSBIO STUDY is an international, multicenter clinical study performed to confirm the BH-Pilot 2015 results and to achieve the IMMUNOBIOGRAM® technical validation. It was performed in nine major University Hospitals in Europe and USA:
- Hospital del Mar, Parc de Salut Mar. Barcelona (Spain).
- Hospital Vall d´Hebron, Barcelona (Spain).
- Hospital La Paz, Madrid (Spain).
- Hospital Universitario Puerta de Hierro (Madrid, Spain).
- Hospital 12 de Octubre, Madrid (Spain)
- Universitätsklinikum Essen (Germany)
- Rigshospitalet, Copenhagen (Denmark).
- Wroclaw Medical University (Poland)
- Massachusetts General Hospital, Harvard Medical School, Boston (USA).
The study objectives were to evaluate the IMMUNOBIOGRAM® robustness, the association with clinical prognoses and its consistency in Kidney Transplantation (KT) ( 218 patients were recruited and 164 patients were evaluable).
TRANSBIO study had 2 parts:
In part 1, the IMMUNOBIOGRAM® of patients with Bad-Clinical-Evolution (BCE) (with renal function deterioration and immunological markers/signs of graft rejection in previous 12-18 months) and with Good-Clinical-Evolution (GCE) were compared.
The IMMUNOBIOGRAM® (IMBG) allowed to quantify in vitro the sensitivity/resistance profile of patients´ immune cells to IMS. Each patient was classified as sensitive, resistant, partial-sensitive or normal responder per IMS tested.
Additionally, two scores allowed to summarize the IMBG patient profile for all IMS tested (with the Global IMBG Score) or only for the IMS taken (with the Prescribed IMBG Score) in a 7 levels scale, from more sensitive (Se++) to more resistant (Re++).
Significant differences were found in both IMBG Scores between patients with Bad Clinical Evolution and Good Clinical Evolution. The Prescribed IMBG Score showed that each step forward in the scale towards resistance increase the probability of a bad prognosis for the patient in a significant way.
In part 2, the consistency of the IMBG (for two key curve parameters of IMBG dose-response curves, the AUC and ID50) was evaluated. The preplanned intra-subject and inter-time consistency in terms of similarity were reached for AUC, and very close to the target for ID50.
- The IMMUNOBIOGRAM® allows to quantify in vitro patients´ PBMC sensitivity/resistance profile to a panel of seven immunosuppressive drugs in Kidney Transplantation recipients.
- Significant differences were found in terms of the IMMUNOBIOGRAM® patterns of resistance/sensitivity to immunosuppressive medication between patients with a Good Clinical Evolution and Bad Clinical Evolution.
- The IMMUNOBIOGRAM® showed intra-subject and inter-time consistency.