FAVOUR

The human brain has the amazing, though limited, ability to repair itself by generating neurons from stem cells, as observed in adult humans. Recent animal studies have shown that the brain is not only capable of transforming lesioned regions into viable territories, but also to reconnect these territories with the healthy brain. However, such prowess is only possible thanks to support matrices, biomaterials that are implanted in the lesion. These biomaterials can even guide tissue regeneration if they are skilfully designed and shaped. FAVOUR opens the way to brain repair and deficit recovery even from extensive damage, such as in TBI or stroke. These neurological pathologies constitute a serious public health problem and have an ever-increasing economic cost. In the case of TBI, severe cases characterized by intracranial hypertension may require a decompressive craniectomy to resolve the oedema. After that, the bone flap is repositioned through a procedure which constitutes an opportunity for the implantation of biomaterials. FAVOUR presents two arms: a preclinical MRI study in implanted animals (part 1) and a clinical trial in patients with TBI (part 2, a first-in-man project). The preclinical component will end up exploring in vivo in marmosets the functional reconnections that will be established within the tissue regenerated by functional MRI and will produce a bimodal MRI-histology visualization program. Then, FAVOUR will test for the first time in humans the feasibility and safety of implants for post-TBI. Among the materials routinely implanted in neurological patients, silicone is a perfect candidate because it is clinically approved, flexible and therefore suitable for soft tissues, easy to shape, non-degradable and non-allergenic. Implants attract the host's stem cells, making the regeneration process extremely safe, without injection of foreign and transformed cells. FAVOUR can be positioned as a personalized-medicine project, because it targets patient’s destroyed bundles of neurons.