Transcript Project leader - Nanoelectronics Forum 2016

“This project has received funding from the European Union’s Seventh
Framework Programme for research, technological development and
demonstration under grant agreement no 318372”.
NANODEM
NANOphotonic DEvice for Multiple therapeutic drug monitoring
General description
 Therapeutic drug monitoring (TDM) in transplanted patients is one of
the crucial aspects in order to define the correct drug dosage of
immunosuppressants.
 Standard techniques are based on the measurement of the trough
concentrations (i.e. the drug plasma level measured just before the
next dose) by use of analytical procedures such as laboratory
immunoassays, high-pressure liquid chromatography (HPLC) or liquid
chromatography combined with mass spectrometry (LCMS).
 Recent clinical studies have indicated that the area under the
concentration time curve (AUC) of immunosuppressant
concentrations well correlate with efficiency and side effects of
immunosuppressive drugs.
 A novel POCT (point of care testing) device – enabling the AUC
measurement of immunosuppressant drugs (cyclosporin A,
tacrolimus and mycophenolic acid) – is strongly required by clinicians
for dose-adjustment immediately after the transplantation.
Goals / Objectives
The main objective of the project is the development of a therapeutic
drug monitoring POCT device for the detection of immunosuppressants
in transplanted patients and its evaluation in clinical settings. The body
interface is an intravascular microdialysis catheter capable to extract the
circulating free fraction of the immunosuppressant. This implies:
•
development of optical biosensors for immunosuppressants and
their integration in a multi-parameter chip
•
development of a luminescence-based optoelectronic system for
the interrogation of the multianalyte chip
•
development of a microdialysis-based body interface
•
integration of the different modules in a compact POCT device
•
clinical assessment of the system on specific classes of transplanted
patients
Partners
• Consiglio Nazionale delle Ricerche
⁻ Institute of Applied Physics (IFAC)
⁻ Institute for Electromagnetic Sensing of the
Environment (IREA)
• University of Tübingen
Institute of Physical and Theoretical Chemistry (EKUT)
• INESC - Microsystems and Nanotechnologies
• Klinikum rechts der Isar der Technischen Universität
München (TUM)
Institut für Klinische Chemie und Pathobiochemie
• Universidad Complutense de Madrid (UCM)
Faculty of Chemistry
• University of Stuttgart (USTUTT)
Institute for Photovoltaics
• Datamed S.r.L. (DM)
• Microfluidic ChipShop GmbH (MFCS)
• Probe Scientific Ltd (PROBE)
Countries involved
Societal impact / Results
The final prototype was manufactured and it is presently under
characterization. The proposal to the Ethics Committee of the university
hospital Klinikum rechts der Isar of Munich was submitetd and clinical
assessment will start within the end of the project (December 2016).
The new tool will allow the automatic measurements of therapeutic
drugs and metabolites characterized by a narrow therapeutic range and
serious potential side effects and the clinical benefit will be an
optimized dosage of the respective therapeutical drug.
Looking ahead
Additional information
Clinical validation is the following necessary step to show the validity
and the reliability of the measurement as well as to demonstrate
that the free fraction of the immunosuppressant is the more reliable
and meaningful clinical value with respect to the whole blood
concentration.
Nanodem video “Between
infection and rejection” is
available on the web page
of the project or at
https://www.youtube.com
/watch?v=-CCDvi-R0hg
Project leader: Francesco Baldini
Company: CNR-IFAC
Email: [email protected]
Tel.: +39 055 5226323
http://nanodem.ifac.cnr.it
http://ec.europa.eu/