UnknownNot Applicable

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

Russia300 participantsStarted 2023-11-13

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Spinal fusion

Timeframe: 6 and 12 months after intervention

Adverse events and Severe Adverse Events

Timeframe: Within 1 year after intervention

Trial details

NCT IDNCT06365307

SponsorHistograft Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-01

Contact for this trial

Renat Nurmukhametov

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

View on ClinicalTrials.gov More Cervical Disc Disorder With Radiculopathy trials