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

H

Histograft

Status

Enrolling

Conditions

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

Treatments

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

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)

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

Trial contacts and locations

1

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Central trial contact

Renat Nurmukhametov

Data sourced from clinicaltrials.gov

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