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 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 Transvaginal meshes are now withdrawn from the market in many countries due to high complication rates.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. Strong CAM sheets are cut to produce threads 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 mechanical properties justifying a preclinical test.
2) In vivo validation of an allogenic CAM mesh (i.e. ovine in ovine) in a female sheep model at 2 and 6 months.
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, allogenic, 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 (TRL) 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.
