RecruitingNot ApplicableNCT06365307

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

Sponsor

Histograft Co., Ltd.

Enrollment

300 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Min Age: 18 Years

Inclusion Criteria2

signing the informed consent
indications for spinal fusion: degenerative-dystrophic diseases of the cervical and lumbar spine.

Exclusion Criteria6

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTOsteoplastic 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.

OTHERSynthetic osteoplastic material based on β-TCP or bone autograft

Locations(1)

Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky"

Moscow, Moscow Oblast, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06365307