Clinical Trial of Device and Growth Factor for Regenerative Treatment of Spinal Cord Injury

Purpose and goal

BioArctic develops a novel treatment of spinal cord injury (SCI). The method is based on the regeneration of functional nerves in the injured spinal cord. Nerve grafts are transplanted into the injured spinal cord, by using a biodegradable device, loaded with nerve grafts and growth factor. Efficacy and safety of the treatment has been demonstrated in a preclinical in vivo model of SCI. The project now enters clinical development in collaboration with neurosurgeons at the Karolinska University Hospital, with a first clinical trial of the treatment of spinal cord injury in man.

Results and expected effects

Today there is no regenerative therapy available for complete spinal cord injuries. A clinical trial of the treatment would be very valuable to the project. A successful therapy would be of tremendous value to patients suffering from spinal cord injury, and would also reduce costs for society. An efficient therapy of spinal cord injury will allow patients globally to be treated. The therapy has been designated Orphan Drug status in Europe and in the USA.

Approach and implementation

In the first phase of the project, devices and growth factor were produced and released for clinical trials. Successful stability studies have been performed with device and growth factor. Preclinical in vivo studies have been performed to optimize surgical procedures and for safety assessment of the therapy. Data have been compiled and the project is to enter clinical development.