The Petrovsky Russian Scientific Center for Surgery is conducting a clinical trial of a gene-activated osteoplastic material for the treatment of patients with spinal diseases. More than 200 patients have already been enrolled. A total of 300 patients will be enrolled.
The gene-activated material for bone grafting was developed by a Skolkovo resident, Histograft (Artgen Biotech Group, MOEX: ABIO), in partnership with the research group led by V.S. Komlev, a Corresponding Member of the Russian Academy of Sciences (Baikov Institute of Metallurgy and Materials Science of the RAS). The material consists of octacalcium phosphate-based granules coated with plasmid DNA molecules carrying the vascular endothelial growth factor (VEGF) gene.
Degenerative-dystrophic spine diseases are one of the main causes of back pain and radiculopathy. The primary method of surgical treatment for these condition is spondylodesis: an operation aimed at immobilizing adjacent vertebrae by creating a bone fusion between them. Globally, 1.5 million such operations are performed every year. As estimated by Histograft, about 40 thousand operations per year are performed in Russia.
The Histograft material has been used in clinical practice for bone grafting since 2020. However, it was previously used to treat spinal diseases only in isolated cases. The clinical trial being conducted at the Petrovsky Russian Scientific Center for Surgery is focused on systematizing data on the safety and effectiveness of Histograft for the treatment of patients with degenerative-dystrophic spine diseases, as well as at developing clinical guidelines for the use of gene-activated osteoplastic material in spinal surgery.
According to the principal investigator, head of the spinal neurosurgery department of the Petrovsky Russian Scientific Center for Surgery, Renat Madekhatovich Nurmukhametov, PhD: “Histograft is convenient to use when performing interbody spondylodesis, it easily fills titanium cages used to fix the vertebral bodies. The patients’ postoperative period is smooth and without complications. Patient enrollment began in February 2024, and the first patients already reached the point of the initial CT-based performance assessment at 6 months. We plan to analyze the results after the trial is completed.”
Histograft is a pioneer in the development and implementation into clinical practice of gene-activated materials for the regeneration of “hard” and “soft” tissues. The company has created a unique technology platform protected by Russian and international patents on the basis of which it is developing a family of implantable medical devices in various forms, consisting of biocompatible materials and nucleic acid molecules, “matrices” for the temporary synthesis of therapeutic protein.
The company’s first product, a gene-activated material for bone grafting called Histograft, became the world’s first-in-class device approved for clinical use. The material was developed in collaboration with the research group led by V.S. Komlev, a Corresponding Member of the Russian Academy of Sciences (Baykov Institute of Metallurgy and Materials Science of the RAS), with the support of Artgen Biotech, Skolkovo Foundation, Foundation for Assistance to Innovations. The material has been used in clinical practice for bone grafting since 2020; more than 5,000 patients have been treated so far. The company is currently conducting studies of the use of Histograft in various areas of surgery.
Artgen Biotech is a biotechnology company with a portfolio of innovative platform developments to implement in health care. The Artgen Biotech Group includes companies at various stages of development — from seed to early growth and maturity, as well as companies forming a biotech development acceleration ecosystem within the group.