Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365307
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-08
Brief Title:
Comparative Study of Gene-Activated Bone Substitute Histograft for Lumbar and Cervical Spinal Fusion
Sponsor:
Histograft Co Ltd
Organization:
Histograft Co Ltd
Study Overview
Official Title:
Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material Histograft in Patients With Degenerative Diseases of the Lumbar and Cervical Spine
Status:
RECRUITING
Status Verified Date:
2024-04
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 goal of this clinical trial is to evaluate the safety and efficacy of the combination product Histograft a bone substitute based on octacalcium phosphate OCP and plasmid DNA encoding VEGFA gene in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP
Detailed Description:
An open-label non-randomized controlled clinical trial will be conducted with two groups of patients Following enrollment based on specific indication criteria all patients will undergo surgical treatment spinal fusion using either bone substitute Histograft for spinal fusion of cervical and lumbar spine or bone autograft for spinal fusion of lumbar spine or synthetic material based on β-TCP for spinal fusion of cervical spine The primary outcomes will involve the bone fusion rate evaluated with computer tomography CT at 6 and 12 months For the safety assessment the frequency of serious adverse events SAEs and adverse events AEs will be monitored throughout the entire clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None