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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Stenosis; Cervical Disc Disorder With Radiculopathy; Biomechanical Lesion, Unspecified; Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renat Nurmukhametov; Phone Number: +7(965)437-8946; Email: ethic@med.ru

Study Locations

• Russian Federation
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russian Federation, 117588
      • Recruiting
      • Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky"
      • Contact: Renat Nurmukhametov; Email: ethic@med.ru
      • Contact: Mark Aleksanyan
      • Principal Investigator: Renat Nurmukhametov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical group; 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	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.
Active Comparator: Control group; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal fusion	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)	6 and 12 months after intervention
Adverse events and Severe Adverse Events	Frequency of Adverse and Severe Adverse Events after treatment	Within 1 year after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Histograft Co., Ltd.
• Collaborators: Petrovsky National Research Center of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bone graft; Spinal fusion
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Bone Diseases; Radiculopathy; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: Histograft-SF-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No