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A completely biological and human tissue-engineered mesh produced from Cell-Assembled extracellular Matrix (CAM) in vitro for the treatment of Pelvic Organ Prolapse (POP)

Project description

A regenerative solution for pelvic organ prolapse

Pelvic organ prolapse (POP) is a condition in which one or more pelvic organs drop from their position and may require surgery. Synthetic transvaginal meshes were previously widely used but have been withdrawn due to high complication rates. In the quest for safer alternatives, the ERC-funded POPTex project proposes developing a tissue-engineered solution based on an extracellular matrix produced by cells in vitro. Scientists will generate extracellular matrix sheets and validate them as an alternative to synthetic meshes. Using a sheep model, they will validate the mechanical properties and effectiveness of this regenerative approach for POP treatment before advancing to clinical trials.

Objective

Pelvic Organ Prolapse (POP) is a major medical issue for women. It is estimated that 1 in 10 women will undergo a surgery to treat POP during her lifetime. To provide mechanical support to the slipping organ, strong and stiff synthetic meshes have been used. Transvaginal meshes are now withdrawn from the market in many countries due to high complication rates. Hence, there is a strong medical and societal need for breakthrough innovations.

We propose a new paradigm targeting the fundamental problem of synthetic meshes, i.e. the foreign body reaction, by providing a completely biological, tissue-engineered mesh to treat POP. Our strategy is based on a unique, biological material: the Cell-Assembled extracellular Matrix (CAM) produced by cells in vitro. Robust CAM sheets are cut to produce yarn subsequently knitted into a mesh.

In 12 months, this proof of concept (PoC) aims to deliver unambiguous experimental evidence that a CAM-based tissue-engineered mesh has the potential to become a relevant alternative surgical solution to treat POP. This project is divided in 2 main tasks:
1) Production and mechanical characterization of a human CAM mesh, and of an equivalent ovine mesh, with properties justifying a preclinical test.
2) In vivo validation of an allogenic CAM mesh in a female sheep model at 2 and 6 month.

This PoC will provide:
1) Proof that a human CAM-based knitted mesh can have clinically relevant mechanical properties;
2) Demonstration that an ovine CAM mesh can be successfully implanted to treat POP in a clinically relevant, allogeneic, large animal model;
3) Direct comparison between the biointegration of an ovine CAM mesh setting and the inflammatory response to a synthetic mesh.

Overall, this PoC will increase the technology readiness level of our product from 1-2 to 3-4 by validating the functionality and safety of CAM meshes in a relevant in vivo environment. These outcomes will lead us closer to clinical trials and support a commercial endeavor.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-ERC-POC - HORIZON ERC Proof of Concept Grants

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) ERC-2022-POC2

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Host institution

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 150 000,00
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

No data

Beneficiaries (1)

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