SC0806 – Complete Spinal Cord Injury

BioArctic is developing an innovative treatment for Complete Spinal Cord Injury.

The product under development, SC0806, consists of 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. Currently there is a Phase 1/2 clinical trial ongoing.

Link to ClinicalTrials.gov.

Co-funded by the European Union

This project, SC0806, has received funding from the European Union’s Horizon2020 Research and Innovation Program under Grant Agreement No. 643853 to perform a clinical study.

The drug candidate received Orphan Drug Designation in EU 2010 and in the US 2011.

Clinical trials are ongoing in Sweden with partners at Karolinska University Hospital and the physiotherapeutic rehabilitation clinics; Rehab Station Stockholm, Sweden, Laitila Rehabilitation Clinic, Finland, Haukeland University Hospital, Neurological Clinic, Bergen, Norway and Haapsalu Neurological Rehabilitation Centre, Haapsalu, Estonia.

The first Lokomat™ walking training robotic system has been installed in Sweden at Rehab Station Stockholm (RSS). The project has introduced and installed new cutting-edge technology in Sweden for physiotherapeutic rehabilitation of Complete Spinal Cord Injury patients.

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 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 major challenges to maintain an acceptable quality of life. 40 percent 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.

To repair of the permanently injured spinal cord has been a huge challenge. The poor prognosis in combination with the absence of effective treatments to restore functional loss has caused communities and countries to focus attention on the provision of basic and essential long-term care services. The cost for society today for patients with Spinal Cord Injury is huge. The estimated lifetime cost is approximately MUSD 3 for one patient.

Discoveries offering a potential regenerative treatment of Complete Spinal Cord Injury

A unique treatment method for Complete Spinal Cord Injury was initially developed at the Karolinska University Hospital/Karolinska Institutet in Sweden. A 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, BioArctic initiated the development of a biodegradable device. It 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 ongoing clinical trial at Karolinska University Hospital with BioArctic as sponsor. BioArctic AB holds patents covering the SCI-device and the treatment method.

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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.