NCT02490501

Safety and Efficacy of SC0806 (Fibroblast Growth Factor 1 and a Device) in Traumatic Spinal Cord Injury Subjects

An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects With Traumatic Spinal Cord Injury

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: BioArctic AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open, randomized, rehabilitation-controlled study in subjects with complete Traumatic Spinal Cord Injury, where the active treatment consists of a surgical implantation of SC0806 (a biodegradable device with heparin-activated FGF1 and nerve implants).

Detailed description

The study is a single dose study in up to 3 sequences in subjects with complete Traumatic Spinal Cord Injury. In each sequence, 6 subjects will be randomized to a surgical procedure where SC0806 will be implanted into the spinal cord and receive specific walking training, and 3 subjects will be randomized to specific walking training only. Interim analyses of safety parameters will be performed. If a positive effect and no major safety concerns have been demonstrated after completion of all sequences, the control subjects will be given the opportunity to receive treatment with SC0806 after completion of their rehabilitation periods.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
PROCEDURE	SC0806 and rehabilitation
OTHER	Rehabilitation only

Timeline

• Start date: 2015-06-01
• Primary completion: 2020-10-01
• Completion: 2025-05-01
• First posted: 2015-07-03
• Last updated: 2025-09-22

Locations

1 site across 1 country: Sweden