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

Not Applicable

Recruiting

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

• Registration Number: NCT06365307
• Lead Sponsor: Histograft Co., Ltd.

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-11-13
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-15
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-09-01
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Synthetic osteoplastic material based on β-TCP or bone autograft	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
Clinical group	Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft")	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

Primary Outcome Measures

Name	Time	Method
Adverse events and Severe Adverse Events	Within 1 year after intervention	Frequency of Adverse and Severe Adverse Events after treatment
Spinal fusion	6 and 12 months after intervention	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)

Secondary Outcome Measures

Name	Time	Method
Unexpected Adverse Drug Reaction	Within 1 year after intervention	Identification of Unexpected Adverse Drug Reaction
SF- 36 score (The Short Form-36)	6 and 12 months after treatment	Assessment of life quality. A score value is ranging from 0 to 100. Higher scores indicate better health status

Trial Locations

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, Russian Federation