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Ambulatory Bio-Artificial Lung

Objective

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death worldwide. Long-term respiratory support increases the life expectancy and the quality of life of COPD patients and decreases the cost of care. Currently available artificial lungs, such as Novalung’s iLA system, fail after ~ one month, mainly due to thrombus formation at the blood/machine interface. The size of current systems restrict patient mobility. We aim to create a wearable bioartificial lung (AmbuLung) for long-term application in an outpatient setting. The goals are to (1) miniaturise the existing iLA system, including the supporting technology and patient monitoring system; (2) cellularise the diffusion membrane with endothelial cells to decrease thrombogenicity and to increase the gas-exchange rate; and (3) evaluate the developed system in pre-clinical and clinical studies.
The innovation includes (i) development of a novel alveolo-capillary gas-exchange membrane, functionalised with bioactive molecules and seeded with endothelial cells, ii) miniaturisation of mechanical and electronic device components, and (iii) novel vascular access system. For cellularisation, endothelial cells derived from FDA approved clinical grade human pluripotent stem cells will be used. Cell differentiation, scale-up, seeding, and maintenance will be performed using established automatable and scalable dynamic bioreactor technology. A mathematical model will be developed to predict and refine the function of this complex system in vitro and in vivo.
AmbuLung will be evaluated in a pig model, assessing functionality, and non-thrombogenicity. The data will provide information required for potential clinical transfer. If successful, a clinical trial will be carried out on 5 COPD patients after acquisition of necessary regulatory approvals. Evaluation of efficacy of the intervention will be based on multidimensional health status grading.

Field of science

  • /medical and health sciences/medical biotechnology/cells technologies/stem cells
  • /natural sciences/mathematics/applied mathematics/mathematical model

Call for proposal

FP7-HEALTH-2012-INNOVATION-2
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

NOVALUNG GMBH
Address
Im Zukunftspark 1
74076 Heilbronn
Germany
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 3 435 833,34
Administrative Contact
Joerg Schneider (Mr.)

Participants (4)

KAROLINSKA INSTITUTET

Participation ended

Sweden
EU contribution
€ 61 466,66
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Miles Davies (Mr.)
IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
United Kingdom
EU contribution
€ 1 122 760
Address
South Kensington Campus Exhibition Road
SW7 2AZ London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Shaun Power (Mr.)
UNIVERSITA DEGLI STUDI DI FIRENZE
Italy
EU contribution
€ 250 000
Address
Piazza San Marco 4
50121 Florence
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Giacomo Laffi (Prof.)
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.
Germany
EU contribution
€ 779 940
Address
Hansastrasse 27C
80686 Munchen
Activity type
Research Organisations
Administrative Contact
Christoph Schulte (Mr.)