NCT06365307

Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion

Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material "Histograft" in Patients With Degenerative Diseases of the Lumbar and Cervical Spine

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Histograft Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Disc Disorder With Radiculopathy
• Spinal Stenosis
• Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
• Biomechanical Lesion, Unspecified

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft")	Due to the localization of the pathological process, all patients are divided into two groups: 1 - cervical spine, 2 - lumbar spine. Within these groups, patients are treated with either gene-activated osteoplastic material Histograft or synthetic osteoplastic material based on β-TCP (β-tricalcium phosphate) for spinal fusion of the cervical spine, or with bone autograft for spinal fusion of the lumbar spine.
OTHER	Synthetic osteoplastic material based on β-TCP or bone autograft	Due to the localization of the pathological process, all patients are divided into two groups: 1 - cervical spine, 2 - lumbar spine. Within these groups, patients are treated with either gene-activated osteoplastic material Histograft or synthetic osteoplastic material based on β-TCP (β-tricalcium phosphate) for spinal fusion of the cervical spine, or with bone autograft for spinal fusion of the lumbar spine.

Timeline

• Start date: 2023-11-13
• Primary completion: 2024-09-01
• Completion: 2025-04-01
• First posted: 2024-04-15
• Last updated: 2024-07-23

Locations

1 site across 1 country: Russia