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SC0806 Spinal Cord Injury FGF1/device


SC0806 – Clinical development                                                                             EC logo

                                                                                                               Co-funded by the European Union


BioArctic AB is developing a novel treatment for complete spinal cord injury. This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 643853 to perform a clinical study in patients with a complete spinal cord injury. The product under development SC0806, is a biodegradable device combined with a growth factor designed to support the regeneration of nerves in the spinal cord, as well as restoring its function. The drug candidate received Orphan Drug Designation in EU 2010 and the US 2011. Clinical trials are ongoing in Sweden with partners at Karolinska University Hospital, Sweden and the physiotherapeutic rehabilitation clinics; Rehabilitation Station Stockholm, Sweden; Laitila Rehabilitation Clinic, Finland and additional Nordic clinics. The first Lokomat™ walking training robotic system has been installed in Sweden at Rehabilitation Station Stockholm (RSS). The project has introduced and installed new cutting-edge technology in Sweden, for physiotherapeutic rehabilitation of spinal cord injury patients. Work is ongoing to include sites in additional Nordic countries.

 

Spinal Cord Injury

 

A Spinal Cord Injury (SCI) occurs when trauma or disease damages the spinal cord and results in partial or complete paralysis. The global annual incidence of Spinal Cord Injury (SCI) has been estimated to 22 per million, with approximately 2.5 million survivors living with paralysis. The victims are usually young people. The injury has little effect on life expectancy but leads to enormous challenges to maintain an acceptable quality of life. Forty percent (40%) of all cases have a complete Spinal Cord Injury. Following complete injury, the patient faces a permanent loss of function below the site of injury, with devastating consequences for the patient’s quality of life. Repair of the permanently injured spinal cord has been a huge challenge. The poor prognosis in combination with absence of effective treatments to restore functional loss has caused communities and governments to focus attention on the provision of basic and essential long term care services. The cost for society today for Spinal Cord Injury patients is huge. The estimated life time cost is approximately 3 MEUR for one patient.

 

Discoveries offering regenerative treatment of complete SCI


A unique treatment method for complete spinal cord injury was initially developed at the Karolinska University Hospital/Karolinska Institutet were Fibroblast Growth Factor together with autologous nerve grafts were used to stimulate nerve regeneration over the injury zone in rats (Cheng et al, Science 1996). To refine the surgical procedure and improve precision, development of a biodegradable device was initiated by BioArctic. The device was designed with channels to support and guide regenerative connections between white and grey matter in the spinal cord. This state of the art technique is the basis for the clinical trial now ongoing at Karolinska University Hospital with BioArctic AB as sponsor. BioArctic holds patents covering the SCI-device and the treatment method.




Read more:


Cheng H et al., Spinal cord repairin adult paraplegic rats: partial restoration of hind limb function. Science1996: 273(5274):510-513.


Nordblom J et al., Peripheral nerve grafts in a spinal cord prosthesis result in regeneration and motor evoked potentials following spinal cord. Restor Neurol resection.Neurosci. 2009;27(4):285-295.

 

Åberg J et al., Calcium sulfate spinal cord scaffold: a study on degradation and fibroblast growth factor 1 loading and release. J Biomater Appl. 2012;26(6):667-685.


Nordblom J et al., FGF1 containing biodegradable device with peripheral nerve grafts induces corticospinal tract regeneration and motor evoked potentials after spinal cord resection. Restor Neurol Neurosci. 2012;30(2):91-102.