Clinical Trials Logo
  1. Home
  2. Spinal Cord Injury
  3. NCT02490501

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

Spinal Cord Injury Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02490501
Study type Interventional
Source BioArctic AB
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 2015
Completion date December 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02574572 - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury Phase 1
Recruiting NCT05941819 - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury N/A
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Recruiting NCT02331979 - Improving Bladder Function in SCI by Neuromodulation N/A
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02978638 - Electrical Stimulation for Continence After Spinal Cord Injury N/A
Withdrawn NCT02237547 - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury Phase 1/Phase 2
Completed NCT02161913 - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers N/A
Completed NCT02262234 - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study Phase 1/Phase 2
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01642901 - Zoledronic Acid in Acute Spinal Cord Injury Phase 3
Terminated NCT02080039 - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury N/A
Completed NCT01471613 - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury Phase 1/Phase 2
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Completed NCT02149511 - Longitudinal Morphometric Changes Following SCI
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01025609 - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed NCT01086930 - Early Intensive Hand Rehabilitation After Spinal Cord Injury Phase 3
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT01005615 - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury Phase 1/Phase 2