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

Histograft

Status: Enrolling

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

Treatments: Other: Synthetic osteoplastic material based on β-TCP or bone autograft; Combination Product: Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft")

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06365307

Histograft-SF-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Clinical group

Experimental group

Description:

Group of patients, who is treated with usage of Histograft bone substitute (gene-activated matrix based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) in spinal fusion of cervical or lumbal spine

Treatment:

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

Control group

Active Comparator group

Description:

Group of patients, who get standard treatment with usage of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine or use of bone autograft for spinal fusion of the lumbar spine

Treatment:

Other: Synthetic osteoplastic material based on β-TCP or bone autograft