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

Spinal Stenosis Clinical Trial

Official title:

Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material "Histograft" in Patients With Degenerative Diseases of the Lumbar and Cervical Spine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365307
• Other study ID #: Histograft-SF-2023
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Histograft Co., Ltd.
• Contact: Renat Nurmukhametov
• Phone: +7(965)437-8946
• Email: ethic[@]med.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 ß-TCP (ß-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 ß-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 ß-TCP (ß-tricalcium phosphate) for spinal fusion of the cervical spine, or with bone autograft for spinal fusion of the lumbar spine.

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (2)

Lead Sponsor	Collaborator
Histograft Co., Ltd.	Petrovsky National Research Center of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse events and Severe Adverse Events	Frequency of Adverse and Severe Adverse Events after treatment	Within 1 year after intervention
Secondary	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
Secondary	Unexpected Adverse Drug Reaction	Identification of Unexpected Adverse Drug Reaction	Within 1 year after intervention