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

Histograft Co., Ltd.300 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Cervical Disc Disorder With Radiculopathy Spinal Stenosis

Interventions

Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft")COMBINATION_PRODUCT

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.

Synthetic osteoplastic material based on β-TCP or bone autograftOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * signing the informed consent * indications for spinal fusion: degenerative-dystrophic diseases of the cervical and lumbar spine. Exclusion Criteria: * refusal to sign IP * age less than 18 years * history of spinal surgery in the area of planned spinal fusion * decompensated forms of chronic diseases * oncological diseases with identified metastases or risk of metastasis * patient's refusal to participate in the study

Outcomes

Primary Outcomes

Spinal fusion

Vertebral fusion: formation of a "bone block" according to CT data (regenerated bone density between the vertebrae without areas of fibrosis and signs of resorption around metal structures)

Time frame: 6 and 12 months after intervention

Adverse events and Severe Adverse Events

Frequency of Adverse and Severe Adverse Events after treatment

Time frame: Within 1 year after intervention

Secondary Outcomes

SF- 36 score (The Short Form-36)

Assessment of life quality. A score value is ranging from 0 to 100. Higher scores indicate better health status

Time frame: 6 and 12 months after treatment

Unexpected Adverse Drug Reaction

Identification of Unexpected Adverse Drug Reaction