Work package 5

Proof of principle in vivo and translation into a clinical trial

Lead: Universiteit Maastricht, Associate Professor Tim Wolfs

In-vivo validation of ArtPlac, development of a protocol for human application

5.1 In-vivo component verification testing (< 12 h)
Testing in vitro (WP 3.4) and in silico (WP 3.3) needs validation in vivo due to the complexity of blood-device interactions which cannot be mimicked entirely in vitro. We will test the interaction between catheters and umbilical vessels, the effects of coating on blood coagulation and of the extracorporeal circuit on cardiovascular stability, changes in hemodynamics over a 12 h adaptation period after birth. We will use a previously applied protocol with (n= 2x10, 2x7 successful) preterm lambs of 127 days gestational age. The experimental procedure and standardised operating procedures are subject to approval by the Dutch legislative boards. Results from short term in-vivo tests and in-vitro tests will be the basis for device optimisations (WP 3.2).

5.2 Integration of components into artificial placenta prototype for in-vivo validation
For validation of our approach, all components of our artificial placenta system will be manufactured, assembled, sterilised, and delivered to the animal lab in Maastricht for mid-and long-term in-vivo testing under realistic conditions (WP 5.3).

5.3 In-vivo validation of AP prototype in long-term experiments (7 days)
The experience from WP 5.1 will be incorporated into 5.3. We will test the device in the above outlined animal model of preterm lambs (2 x 10) for 7 days and invite parent input. The primary endpoint will be gas exchange, secondary will be electrolyte balance.

5.4 Development of a protocol for human life support application
We have obtained preclinical experience in the application, handling, performance, and maintenance of the device in appropriate animal models. We will use this to facilitate the translation into a clinical trial protocol for babies. We will pay special attention to teaching.

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ArtPlac is a preclinical research project dedicated to develop an innovative technology of medical treatments for neonatal intensive care.


Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.