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A digital tool combined with an in vitro model for improving patient´s care requiring Continuous Renal Replacement Therapy (CRRT)

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOFR20210108001
Publicado:
18/01/2021
Caducidad:
19/01/2022
Resumen:
A French well-known hospital has developed a digital solution (in-vitro model and software) which studies elimination routes of drugs in extracorporeal devices. It provides new insights on intrinsic properties for all types of filters, allowing for systematic evaluation with high repeatability costless, rapid results and performance. Commercial agreements with technical assistance are sought.

Details

Tittle:
A digital tool combined with an in vitro model for improving patient´s care requiring Continuous Renal Replacement Therapy (CRRT)
Summary:
A French well-known hospital has developed a digital solution (in-vitro model and software) which studies elimination routes of drugs in extracorporeal devices. It provides new insights on intrinsic properties for all types of filters, allowing for systematic evaluation with high repeatability costless, rapid results and performance.

Commercial agreements with technical assistance are sought.
Description:
The French adult Intensive Care Unit (ICU) is a leader in kidney transplantation and handles a great variety of extracorporeal devices, which are used in patients presenting acute liver failure not requiring transplantation.

The last 20 years have witnessed an extraordinary development of treatment methods using extracorporeal circulation devices- arterio-venous and vein-venous extracorporeal membrane oxygenation (ECMO); continuous extra-renal purification; molecular Adsorbent Recirculating System - which require long-lasting supportive treatment. These medical devices tend to be associated to the same patient. This situation can be partially justified by the fact that, in opposition to pharmaceuticals, the efficacy and safety of these devices are determined during the clinical development phase only, as no prior preclinical studies are required.

To date, a limited number of adverse effects associated with extracorporeal devices have been identified: haemorrhages; thrombosis; biocompatibility and intravascular hemolysis. Most extracorporeal circulation device manufacturers focus their development strategies on these events, in order to achieve satisfactory levels of material biocompatibility, reduction of hemolysis (non-occlusive pumps) and diminution of hemorrhagic events.

But a severe adverse effect related to the adsorption of drugs administered during continuous extracorporeal blood purification sessions remains poorly documented. Indeed, in routine medical care, clinicians have frequently experienced difficulties in balancing drug administration, which can decrease or even yield complete loss of efficacy resulting in death. Detection of adsorption in vivo can be challenging among patients presenting multiple organ failures, as there are no current approaches that allow for its quantification. Also, no in vitro models are able to respond to the problem of detection and quantification of adsorption in filters sessions in real life. Indeed they never compare this quantity with those carried out by conventional elimination routes (hemofiltration and hemodialysis). Hence, no in vitro model has yielded effective countermeasures for adsorption. This failure of in vitro models is regularly underlined, whereas the recommended therapeutic monitoring is unable to provide a useful response just in time. This situation applies for all drugs of interest in intensive care, including anti-infective agents, even though the effectiveness of the first dose is a decisive parameter for the vital prognosis.

This French solution combines an in-vitro model and software. With a focus on continuous renal replacement therapy (CRRT), this model mimics a session in the different modes of RRT as those used in critically ill patients (dialysis, filtration, and diafiltration). Importantly, it only uses a crystalloid solution in all compartments of the model. The crystalloid solution provides a number of advantages including high standardization and reproducibility of the medium, and understanding on the disposition of the free fraction of drugs; therefore resulting in accurate measurement of the sieving coefficient in the filtration model.

The software does not make any assumption about the time or concentration-dependency of the pharmacokinetics (PK) in the central compartment (CC). It was extended to the molecular adsorbent recirculating system providing support to acute liver failure and could be extended to all extracorporeal devices requiring the presence of a filter for various purposes.

Commercial agreements with technical assistance are sought with manufacturers of extracorporeal devices who are willing to test the solution through the implementation of in-vitro studies, in order to assess the performance of their filters/membranes.
Advantages and Innovations:
As mentioned, the software could be extended to all extracorporeal devices requiring the presence of a filter for various purposes: supplying severe lung and heart failure, as well as kidney and liver failure, as well as adsorptive devices designed for modulation of the cytokine storm triggered by severe sepsis, as well as gene therapies including Car-T-cell administration.

The prerequisites are minimal (solubility and stability in crystalloid solution over 24 hours and a method of measurement of concentrations). The concentrations are measured in a crystalloid solution. Therefore, the solution obviates the need for extraction and requires simple analytical methods based on HPLC combined.

One major advantage is to directly give access to elimination of the free fraction of drugs (fraction of drugs not bound to proteins in plasma) which is the "driving" concentration for diffusion into the body and elimination by extracorporeal devices. This is the "Graal" of all pharmacologists, always outlined but never measured. Only one crystalloid solution is used within all the compartments of the model, results are highly reproducible. Quality control measures are performed randomly.

Non use blood: Blood is an extremely complex and heterogenous medium with a great variability both in specimens used for in vitro model and in critically ill patients. The final aim is to allow each manufacturer to provide good practice recommendations to clinician for the use of drug for the use of each filter. This solution is the first model to provide clarifications through simultaneous quantification of filtration, dialysis, and adsorption in conditions mimicking a session of CRRT.
Stage of Development:
Available for demonstration
IPs:
Secret Know-how

Partner sought

Type and Role of Partner Sought:
The French hospital is looking for manufacturers of extracorporeal devices that are willing to test the solution, in order to assess the performance of their filters/membranes through the implementation of in-vitro studies.

Ideally, a group of pre-defined pharmaceutical treatments - focused on specific diseases - will be tested in the devices, in order to assess the adsorption of these different molecules on device´s filter/membrane.

The solution aims to become a tool that will allow manufacturers to better understand the mechanisms impact of drug adsorption in different compartments, which might constitute a valuable source of information, either in pre and post marketing steps. In this case both new devices (not yet CE marked) or devices already available in the market will be potential partners for this collaboration.

Middle and large sized companies are particularly welcome.

The French hospital will provide the technical assistance necessary to set up the collaboration.

Client

Type and Size of Client:
Other
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
French

Keywords

Technology Keywords:
06001024 Biomateriales médicos
06001016 Fisiología
06001007 Medicina de urgencias
06001013 Tecnología médica / ingeniería biomédica