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

NCT06365307 | Recruiting

• 1 other identifier: Histograft-SF-2023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Spinal fusion; Bone graft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• SF- 36 score (The Short Form-36)

  6 and 12 months after treatment

• Unexpected Adverse Drug Reaction

  Within 1 year after intervention

Study Arms (2)

Clinical group

EXPERIMENTAL

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")

Control group

ACTIVE COMPARATOR

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

Interventions

Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft") COMBINATION_PRODUCT

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.

Clinical group

Synthetic osteoplastic material based on β-TCP or bone autograft OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Histograft Co., Ltd.: lead
• Petrovsky National Research Center of Surgery: collaborator

Study Sites (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, 117588, Russia

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Renat Nurmukhametov

CONTACT

+7(965)437-8946; ethic@med.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the preliminary screening and indication for surgical treatment, patients are divided into 2 groups depending on the location of the pathological process: 1 - cervical spine, 2 - lumbar spine. During independent sequential randomization in a 1:1 ratio, patients in each of these groups are divided into clinical (A) and control (B) groups. Distribution of treatment methods by groups: 1A - use of "Histograft" for spinal fusion of the cervical spine, 50 patients 1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients 2. A - use of "Histograft" for spinal fusion of the lumbar spine, 100 patients 2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 15, 2024
• Study Start: November 13, 2023
• Primary Completion: September 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)