ARTIFICIAL LUNG
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The BioArt-Lung 2020 project is co-laureate of the first wave of ANR (Agence Nationale pour la Recherche)
RHU (Recherche Hospitalo-Universitaire) program.
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This project is coordinated by Pr Olaf MERCIER, senior thoracic surgeon,
head of research and innovation department at Marie Lannelongue Hospital, Professor at Paris South University.
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Thanks to a high-level consortium, based on a strong partnership between academic, clinical and industrial research,
we will be able to achieve the three RHU missions which are “Research”, “Science translation” and “Education”.
The aim is to develop, within 5 years, a total, paracorporeal, miniaturized, artificial lung capable of oxygenation, decarboxylation and right ventricular (RV) unloading -a real cardio-pulmonary unit support.
This would add a novel therapy solution to Pulmonary Hypertension (PH) patients with end-stage Right Ventricular (RV) failure waiting for transplantation.
Additional research will be performed simultaneously with the aim of eventually converting this artificial lung to a bio-artificial lung (i.e. with human cells).
Indeed, a miniaturized and fully endotheliazed artificial lung will definitely contribute for:
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Long term operability
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Ambulatory options
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And improved clinical status before transplantation
Bioart-Lung project development has been divided in 4 Work-Packages (WP). One WP dedicated to overall management of the project and three WP to scientific aspects.
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WORK-PACKAGE 1
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Work Package 1 (WP1), under the leadership of Pr Olivier SITBON (AP HP), aims to develop markers of failing Right Ventricle (RV) for a better understanding of the disease and a better selection of patient before therapy (biomarkers, and functional imaging).
Work Package 2 (WP2), under the leadership of Pr Olaf MERCIER (GHPSJ), aims to specify, design, develop and tests all sub systems which will be integrated to build the total artificial lung.
WORK-PACKAGE 2
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WORK-PACKAGE 3
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Work Package 3 (WP3), under the leadership of Pr Olaf MERCIER (HML), aims to manage, specify, and perform clinical studies and prepare industrial transfer.
Initial timeline of the project
- Biomarkers research
WP 01
WP 03
WP 02
device development -
FIRST IN HUMAN
Devices development
Clinic
trials
2015
2017
2020
2015
2018
2020
Right ventricular failure biomarkers
WORK PACKAGE 1
Work Package 1 (WP1), under the leadership of Pr Olivier SITBON (AP HP), aims to develop markers of failing Right Ventricle (RV) for a better understanding of the disease and a better selection of patient before therapy (biomarkers, and functional imaging). This WP is divided in three tasks.
TASK 1
“Right ventricular function biomarkers” under the leadership of Pr Elie FADEL (HML), aims:
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To determine whether circulating biomarkers may discriminate the extent of interstitial fibrosis in patients with RV pressure overload
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To determine how inflammasome activation can contribute to maladaptive remodeling of right ventricle
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To develop a novel nanotechnology based platform combining the markers of highest yield as determined by previous objectives
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TASK 2
“Pulmonary Hypertension Prognosis Biomarkers” under the leadership of Pr Marc HUMBERT (AP-HP) and Pr Olivier SITBON (AP-HP), aims to discover biomarkers predicting survival in a pulmonary arterial hypertension national cohort.
TASK 3
“A new marker of altered RV metabolism” under the leadership of Christophe JUNOT (CEA LEMM), aims to identify novel targets for metabolic, functional imaging of the RV.
WORK PACKAGE 2
Work Package 2 (WP2), under the leadership of Pr Olaf MERCIER (HML), aims to specify, design, develop and tests all sub systems which will be integrated to build the total artificial lung. This WP is divided in six tasks.
TASK 1
“BioArt-Lung cannula”, under the leadership of Pr Olaf MERCIER (HML), aims to develop a novel double lumens cannula for Right to left atrial extracorporeal circulation.
TASK 4
Next generation of oxygenator”, under the leadership of Dr Anne Marie HAGHIRI (CNRS), aims to specify, design, develop and test a novel endothelial oxygenator based on microfluidics technology.
TASK 2
“Pump, Tubing and Coating”, under the leadership of Pr Olaf MERCIER (HML), aims to develop the next generation of pump, tubing and coating for prolonged extracorporeal support.
TASK 3
“Oxygenator endothelialization”, under the leadership of Dr Georges UZAN (INSERM U1197), aims to develop a robust endothelial cells that will adapt to specific stress conditions of the novel oxygenator and develop and validate oxygenator cells seeding protocol.
TASK 6
“Energy autonomy”, under the leadership of Dr Yvan REYNIER (CEA LITEN), aims to specify, design, and develop a portable long-acting battery.
“BioArt-Lung”, under the leadership
of Pr Olaf MERCIER (HML) aims to specify, design and integrate the total Bio-Artificial lung.
WORK PACKAGE 3
Work Package 3 (WP3), under the leadership of Pr Olaf MERCIER (HML), aims to manage, specify, and perform clinical studies and prepare industrial transfer.
TASK 1
“Cannula Clinical trial”, under the leadership of Pr Olaf MERCIER (HML), aims to manage, specify and perform clinical trial for safety and efficacy of the novel cannula.
TASK 2
“Circuit Trial”, under the leadership of Pr Olaf MERCIER (HML), aims to manage, specify and perform clinical trial for safety and efficacy of the novel circuit components
TASK 3
“Bio-Oxygenator trial”, under the leadership of Pr Olaf MERCIER (HML), aims to manage, specify and perform clinical trial for safety and efficacy of the novel bio-oxygenator.
TASK 5
TASK 4
“Bio-markers trail”, under the leadership of Pr Elie FADEL (HML), aims to manage, specify and perform clinical trial to validate blood biomarkers and new imaging tracers to predict outcomes and RV function in patients with severe PH.
“BioArt-Lung trial”, under the leadership of Pr Olaf MERCIER (HML), aims to manage, specify and perform clinical trial for safety and efficacy of the total Bio-Artificial lung.
The goal is to reduce as much as possible timeframe between preliminary research steps (preclinical research)
and first-in-man innovation implementation (clinical research).
For our project we will closely work with patients association and set-up multi-disciplinary medical
and para-medical team with a first-in-man target by the end of 2020 for the total artificial lung device and RV biomarkers / functional imaging.
objective is to create a worldwide interdisciplinary community (gathering physicians, scientists, industrials and engineers) on Lung Artificial Device thematic which will increase networking inside the community to offer solutions to patients
and teach youngest researchers.
The first triennial periodic world symposium on Artificial Lung support technologies will be held in France in October 2021 gathering international experts and offering round tables, seminars and conferences.
Pr Olaf MERCIER, Marie Lannelongue Hospital, INSERM U999 and Paris Sud University is the scientific coordinator of project BioArt-Lung 2020.
INSERM DR11, member of DHU TORINO, is the financial coordinating structure of the project.
4 committees and a project board are managing the project and have to report bi-annually to the French National Research Agency (ANR).
STEERING COMMITTEE
INTELLECTUAL PROPERTY RIGHTS (IPR) & DISSEMINATION COMMITTEE
CLINICAL COMMITTEE
SCIENTIFIC
COMMITTEE
This committee is chaired by scientific coordinator and composed by one qualified representative of each partners of the project. This committee monitors performances of the whole work done in the frame of the project.
This committee is chaired by scientific coordinator and composed by one qualified representative of each partners of the project. This committee monitors performances of the works done in the frame of “education”, “valorization” and all dissemination activities including industrial technologies transfer.
This committee is composed by independent people in charge of controlling clinical trials especially on pharmacological aspects and all side effects complications occurring during pilot studies.
This committee is chaired by the scientific coordinator and composed of a qualified representative of each project partner. This committee follows the scientific progress and the potential obstacles arising during the project. It also ensures the compatibility of the devices and the collaboration of the teams.
SCIENTIFIC COMMITTEE
Emile BACHA
Gilles BLOCH
Yong CHEN
Alain COMBES
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Chief of Division of Cardiac, Thoracic, & Vascular Surgery
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Director of Congenital and Pediatric Cardiac Surgery at New-York Presbyterian Congenital Heart Center
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President of Paris Saclay University
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Research Director at CNRS
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Professor at Ecole Nationale Supérieure
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Microfluidic expert
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Professor of Medicine at Paris 6 University
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Head of Pitié Salpétrière Intensive Care Department
Didier LETOURNEUR
François HADDAD
Cécile PERRAULT
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Clinical Associate Professor of Medicine at Stanford University
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Head of Stanford Cardiovascular Institute Biomarker and Phenotypic Core Laboratory
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Research Director at CNRS
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Head of INSERM Unit 1148 (Cardiovascular Bio-engineering Laboratory)
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Assistant Professor in the department of mechanical engineering at Sheffield University
Anton VONK NORDEGRAAF
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Head of department of Pulmonary Diseases, VU University Medical Center
PROJECT BOARD
In addition to these committees, the project board chaired by scientific coordinator is managing
all project aspects on a day to day basis.