MedTrace Logo

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

NCT06365307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-07-23

No results posted yet for this study

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Petrovsky National Research Center of Surgery

    collaborator UNKNOWN

  • Histograft Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2024-09-01
Completion
2025-04-30

Countries

  • Russia

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365307 on ClinicalTrials.gov