Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02490501
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2015-06-30
Brief Title:
Safety and Efficacy of SC0806 Fibroblast Growth Factor 1 and a Device in Traumatic Spinal Cord Injury Subjects
Sponsor:
BioArctic AB
Organization:
BioArctic AB
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None