Study of the Therapeutic Effects of Cortical Autograft Implantation in Patients With Cerebral Ischemia — AVCell  

Ischemic Stroke Clinical Trial

Official title: Study of the Therapeutic Effects of Cortical Autograft Implantation in Patients With Cerebral Ischemia

Status Not yet recruiting

Clinical Trial Summary

Brain lesions in the adult have dramatic consequences, because the spontaneous capacity of the brain to functionally recover is limited. Besides existing rehabilitative therapeutic approaches (e.g. physiotherapy), several lines of research aim at developing treatments to promote and refine brain plasticity to enhance functional recovery following brain injury.

This pilot clinical study aims at enrolling subjects victim of a stroke with neuronal destruction leading to a disabling motor deficit. Usually these patients benefit from intensive neurorehabilitation which allows them to progress up to a certain point but when their recovery plateau is reached; current medicine is disarmed and no effective treatment allows, to date, to improve further their performance. This monocentric pilot study aims at evaluating the feasibility and safety of Autologous Neural Cell Ecosystems (ANCE), which is a cortical autograft intended to be used on stroke patients, for the replacement of motor neurons destroyed during an ischemic stroke.

Clinical Trial Description

Using neural grafts to restore function after lesions of the central nervous system is a challenging strategy. Most of the transplantation experience acquired the last decades was focused on fetal neuronal grafts. However, despite the great enthusiasm generated by this approach, ethical controversies, immune rejection, and lack of fetal donors remain a major problem. Therefore, autotransplantation of adult brain cells represents an attractive restoration alternative to bypass the caveats of fetal grafting.

The optimization of the procedure to obtain ANCE, a cortical autograft obtained from cortical biopsy, was first successfully demonstrated in producing long-term primary culture of adult human brain cells from temporal lobe tissues obtained from epilepsy and trauma neurosurgical patients. ANCE has been characterized as an ecosystem of autologous neural cells in suspension, composed of several cell types: astrocytes, proliferative progenitors and quiescent progenitors.

The production of ANCE has been implemented to prepare long-term primary culture from primate cortical biopsies. This allowed assessing the feasibility of autotransplantation from brain biopsy to reimplantation of cultured brain cells in a non-human primate model of motor cortex lesion. On the same model of cerebral cortex lesion in nonhuman primates, further study demonstrated, by quantitative behavioral evidence, the beneficial outcome of cell therapy following injury of the cerebral cortex.

Based on the encouraging results from past experiences on non-human primate model of motor cortex lesion, this monocentric pilot study aims at evaluating the feasibility and safety of ANCE (Autologous Neural Cell Ecosystems), which is cortical autograft intended to be used on stroke patients, for the replacement of motor neurons destroyed during an ischemic stroke. ;

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Ischemia
• Ischemic Stroke

• NCT number: NCT04488965
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Jocelyne Bloch, Pr MD
• Phone: +41795562951
• Email: jocelyne.bloch@chuv.ch
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Completion date: September 1, 2025