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  • Periodic Reporting for period 1 - SC0806 (Regenerative treatment of complete Traumatic Spinal Cord injury with a surgical implantation of a biodegradable device with FGF1 and nerve grafts)

SC0806 Report Summary

Project ID: 643853
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - SC0806 (Regenerative treatment of complete Traumatic Spinal Cord injury with a surgical implantation of a biodegradable device with FGF1 and nerve grafts)

Reporting period: 2015-01-01 to 2016-06-30

Summary of the context and overall objectives of the project

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. The cost for society today for Spinal Cord Injury patients is huge. The estimated life time cost is approximately 3 MEUR for one patient.

The overall objective of the project is to perform a clinical trial of a novel regenerative treatment of complete Spinal Cord Injury. Today there is no efficacious treatment for these patients.
The clinical trial is an open, randomized, rehabilitation-controlled study, to assess safety, tolerability, and efficacy, of heparin-activated recombinant human fibroblast growth factor 1 (FGF1), on a biodegradable device, in subjects with traumatic spinal cord injury.

The therapy and the clinical trial, involves surgery followed by a period of physiotherapy training (18 months) of patients. Control subjects will receive physiotherapy training only. If efficacy is seen in the regenerative treatment, control subjects will be offered the complete treatment including surgery. In total 27 patients will be included in the study covering Sweden and other Nordic countries including Finland. The surgery will be performed at one clinic, at the Karolinska University Hospital in Stockholm, Sweden. Patients will be recruited within Sweden and other Nordic countries including Finland. Post-surgery physiotherapy training and rehabilitation, using state-of the art robotics technology (Lokomat), will be performed at the rehabilitation clinics. The therapy for complete SCI that will be evaluated in the study, addresses a world market and a global health issue, for which there are currently no regenerative treatments available. The primary objectives of the project are i) To assess the safety and tolerability of one implantation of SC0806 (SCI-device with nerve grafts and heparin-activated FGF1) in subjects with complete Traumatic Spinal Cord Injury. ii) To evaluate the efficacy of one implantation of SC0806 on electrophysiology in subjects with complete Traumatic Spinal Cord Injury from baseline to 18 months.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

SCI-Devices and FGF1 Drug Product have been produced in a timely manner to enable the efficient conduct of the clinical study as outlined in the objectives. The material has been released for clinical use, and delivered to the clinical trial site. The full documentation and application to start clinical trials with the SCI-Device and FGF1 Drug Product has been prepared, submitted to, and approved by the Swedish Medical Products Agency (MPA) and the Ethics Committee. The study has been registered at, WHO International Clinical Trials Platform and EU Clinical Trials Register. The first Lokomat walking training robotic system has been installed in Sweden at Rehabilitation Station Stockholm (RSS). The project has thus introduced and installed new cutting-edge technology in Sweden, for physiotherapeutic rehabilitation of spinal cord injury patients. The clinical study on the regenerative treatment of patients with complete spinal cord injury has successfully started and is ongoing in Sweden. Preparations are ongoing to initiate site in Finland and to include sites in other Nordic countries.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Current state-of-the-art: Spinal Cord Injury causes degeneration of the white matter distal to the site of injury. Subsequently the axon fails to regenerate across the Spinal Cord Injury because of the local inflammatory environment in the spinal cord. This inflammatory reaction causes glial proliferation, migration and the local release of several pro-inflammatory cytokines resulting in an astroglial scar. In addition, several local factors that prevent the regeneration of nerves in the CNS have been identified to be excessively released. As a result, complete SCI leads to permanent loss of neurological function. Today, no regenerative treatment method, feasible for clinical practice, exists for complete SCI. To the best of our knowledge, BioArctic together with the collaborators are pioneering this segment of unmet medical need. BioArctic holds patents covering the device and the treatment method. Other companies mainly focus on developing therapies for a different group of patients with partial sensory functions retained as a result of partial (incomplete) SCI or acute injuries.

Progress beyond state-of the art: The treatment method developed by BioArctic utilizes the ability of central nerves to grow in transplanted grafts of peripheral nerves that shield the regenerating nerves from the local inflammatory environment at the site of injury. Several peripheral nerve grafts are transplanted into the biodegradable device that acts as support for guided nerve regeneration between the upper and lower portion of the damaged spinal cord. The strategy is based on the use of a device with channels for the peripheral nerve grafts. The entrance and exit holes in the device have been localized for optimal coupling between descending motor tracts and motor neuron pools as well as for the ascending sensory system and sensory neuron pools. This design supports and guides regenerative connection between white and grey matter in the spinal cord. The device allows for nerve graft positioning with high precision during surgery. The device is biodegradable and biocompatible, leaving no traces in the healed wound, thus avoiding the risk for long-term potential problems with non-degradable implants. To further stimulate nerve generation the device is loaded with the growth factor FGF1, which is slowly released as the device is degraded. FGF1 is a well characterized growth factor present in neurons and involved in nerve regeneration and healing. The combination of FGF1 and peripheral nerve grafts creates a favorable environment for axon regeneration. It is known that heparin binds and activates FGF1. Hence, to achieve full activity, FGF1 is formulated with heparin. The device containing heparin-activated FGF1 is used during the neurosurgical procedure, to replace injured tissue and to connect viable nerves to the other side of the injured segment.

Expected potential impact and advancement: The project is expected to translate our preclinical discoveries, offering a new regenerative treatment of complete SCI, into an effective therapy in clinics, where it may restore lost function to potentially thousands of SCI patients worldwide. The treatment concept holds the potential for significantly improving quality of life of many patients.

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