Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01106417
Status:
COMPLETED
Last Update Posted:
2020-06-29
First Post:
2010-04-16
Brief Title:
Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
Sponsor:
Mesoblast Ltd
Organization:
Mesoblast Ltd
Study Overview
Official Title:
Phase 2 Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion With Anterior Cervical Plate Fixation
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
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:
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease DDD at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1 All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation
Detailed Description:
This is a prospective multicenter randomized single-blinded controlled study evaluating safety and preliminary efficacy of immunoselected culture-expanded nucleated allogeneic MPCs NeoFuse combined with MasterGraft Matrix in a commercially available PEEK cervical Spacer compared to an active control in subjects undergoing 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation
After the screening and surgical visits each subject will be evaluated clinically and radiographically within 3 days and 30 days after surgery and at 3 6 12 and 24 months after surgery
Subjects will be evaluated at the same time points for safety
After the screening and surgical visits each subject will be evaluated clinically and radiographically within 3 days and 30 days after surgery and at 3 6 12 and 24 months after surgery
Subjects will be evaluated at the same time points for safety
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