The biotech company Histograft (part of the Artgen Biotech group, MOEX: ABIO) has begun clinical studies of gene-activated osteoplastic material for the treatment of patients with degenerative diseases of the spine.
Degenerative-dystrophic diseases of the spine occupy one of the first places in the frequency of identified pathologies of the musculoskeletal system and are one of the main causes of back pain and the development of radiculopathy.
In December 2023, Histograft and the Russian Scientific Center for Surgery named after Academician B.V. Petrovsky signed a cooperation agreement aimed at increasing the effectiveness and safety of treatment for patients with degenerative-dystrophic diseases of the spine, the main method of surgical treatment of which is interbody fusion.
The controlled comparative study will involve 300 patients with degenerative diseases of the lumbar and cervical spine for which interbody fusion is indicated. Surgeries for 150 patients will be performed using the Histograft material.
Histograft has already been approved for clinical use in traumatology practice, but to date clinical data have not been accumulated for the large-scale introduction of the product in this segment of medical indications. The launched clinical trial is designed to fill this lack of information, systematize data on the safety and effectiveness of the Histograft osteoplastic material in the treatment of patients with degenerative-dystrophic diseases of the spine, and formulate clinical recommendations for the use of osteoplastic material in spinal surgery. According to Histograft, about 40 thousand interbody fusions are performed annually in Russia; each surgery requires 2 to 5 cm3 of material. Spinal fusion is the largest segment of the global osteoplastic materials market; according to various estimates, 1.5 million such surgeries are performed annually worldwide and their number is constantly growing with an increase in the proportion of the population over 50 years of age.
Histograft is a pioneer in the development and introduction into clinical practice of gene-activated materials for the regeneration of "hard" and "soft" tissues. The company has created a unique technological platform, protected by Russian and international patents, on the basis of which it is developing a line of implantable medical products in various forms (granules, gels, membranes, personalized implants), consisting of biocompatible materials and nucleic acid molecules - "matrices" for temporary synthesis of therapeutic protein, indicated for the regeneration of various tissues.
The company's first product, the gene-activated material for bone grafting Histograft, became the world's first product in this class approved for clinical use. The material was developed in partnership with the scientific group of Corresponding Member of the Russian Academy of Sciences V.S. Komlev (Institute of Metallurgy and Materials Science named after A.A. Baikov, RAS), with the support of Artgen Biotech, Skolkovo Foundation, Innovation Promotion Fund. The materials has been used in clinical practice for bone grafting since 2020, with more than 3,500 patients treated to date. The company is currently working on conducting research on 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 healthcare. The Artgen Biotech group includes companies at different stages of development - from the seed stage to the stage of early growth and maturity, as well as companies that form an ecosystem for accelerating biotech developments in the group.