This startup develops a biomaterial and stem cell therapy for sub-acute spinal cord injury repair. Their platform combines an injectable, resorbable hydrogel with autologous stem cells to promote tissue plasticity and guide damaged tissue toward self-regeneration, aiming to restore cord functionality.
Funding
Funding not disclosed
Founders
Product
Problem
Spinal cord injuries often result in permanent neurological impairments due to the complex cascade of events following the initial trauma. Current therapies often target only single components of this multifaceted pathology, leaving significant unmet clinical needs in restoring cord functionality.
Solution
Regenera is developing a combined biomaterial and stem cell therapy, SpinoSave®, for sub-acute spinal cord injury repair. The approach involves grafting autologous stem cells, hosted within an injectable, resorbable hydrogel, outside the lesioned parenchyma during post-traumatic stabilization surgery, following standard anti-inflammatory therapy. The hydrogel provides trophic support to promote tissue plasticity, while the paracrine effect of the stem cells guides the damaged tissue toward self-regeneration, aiming to restore motor and sensory function. In vivo model studies have demonstrated improved motor and sensory performances.
Target Audience
The primary target audience includes medical professionals specializing in spinal cord injuries, such as neurosurgeons and rehabilitation specialists, as well as hospitals and clinics focused on treating patients with sub-acute spinal cord injuries.
Features
- Injectable, resorbable hydrogel (SpinoSave®) designed to host and deliver autologous stem cells.
- Autologous stem cell therapy leveraging paracrine effects to stimulate tissue regeneration.
- Application during post-traumatic stabilization surgery, following standard anti-inflammatory therapy.
- Demonstrated improvement in motor and sensory performances in in vivo models.
- Classified as an Advanced Therapy Medicinal Product (ATMP) and Tissue Engineered Product (TEP) by the European Medicines Agency (EMA).
- Swiss orphan status designation for the treatment of acute spinal cord injury granted by SwissMedic.
- EMA orphan medicinal product designation for SpinoSave®.