Recently, the clinical research project of stem cell 3D bioprinting blood vessels, which was applied by West China Hospital of Sichuan University and provided products and technical services by Sichuan Blu-ray Inno Biotechnology Co., Ltd. Commission filing agrees. In 2022, the stem cell clinical research will be carried out in West China Hospital of Sichuan University.
Founded in 2014, Blu-ray Inno is a high-tech enterprise focusing on stem cell tissue repair and regeneration. The company has independently developed the world's first stem cell Biosynsphere® (Biosynsphere®) technology platform with independent intellectual property rights, and based on this technology platform has developed a stem cell 3D bioprinted blood vessel (REVOVAS®), which has great clinical application value and is a stem cell A major breakthrough in tissue repair and regeneration.
Stem cell 3D bioprinted blood vessels REVOVAS®
REVOVAS® uses autologous adipose-derived mesenchymal stem cells as bio-ink raw materials, and prints biologically active blood vessels through a self-developed 3D bio-vascular printer, and implants receptors to replace diseased blood vessels. In the animal experiments of rhesus monkeys and Wuzhishan miniature pigs of this technology, it was observed that the implanted blood vessels achieved complete vascular tissue regeneration in a short period of time, with the function of normal blood vessels.
At present, Blu-ray Inno has completed vascular pharmacy and pharmacology and toxicology related research on stem cell 3D bioprinting, including process and quality research under GMP conditions, nearly 100 rhesus monkeys and Wuzhishan miniature animal experiments under GLP conditions, among which rhesus monkeys were observed The longest cycle has exceeded 1700 days, and all safety indicators have met the requirements. No stenosis of the regenerated blood vessels has occurred, and the recipient does not need to take anticoagulant drugs for a long time after surgery.
Blu-ray Inno has also built a complete quality management system throughout the life cycle of stem cell 3D bioprinted blood vessel products, including nearly a thousand SOPs such as R&D management, production management and animal experiment management systems, from raw materials, intermediate products to final products. Complete quality control standards have been established.
Stem cell 3D bioprinted blood vessels have superior performance in long-term patency rate and "autonomous" blood vessel formation. Once applied to the clinic, it will solve the problem of artificial blood vessel endothelialization that has plagued humans for half a century.
△Bio-brick preparation system (first from left, second from left) and real shot of bio-brick (first from right)
Under the background of the innovation of the national stem cell clinical research mechanism, the stem cell 3D bioprinted blood vessel technology is supported by regulatory agencies at all levels, and clinical research will be carried out in West China Hospital of Sichuan University in 2022. At the same time, Blu-ray Inno will continue to supplement the experimental data materials in accordance with the clinical trial application requirements of China CDE and the US FDA, and continue to promote the clinical trial and product marketing of the stem cell 3D bioprinted blood vessel project.
Outlook
With the development of society and economy, our lifestyles have changed, especially the aging of the population and the acceleration of urbanization. Unhealthy lifestyles have become increasingly prominent. Cardiovascular disease has become the number one health killer beyond tumors, and the incidence rate is still increasing. .
According to the statistics of "China Cardiovascular Health and Disease Report 2020", cardiovascular disease currently accounts for the first cause of death among urban and rural residents in China, with 46.66% in rural areas and 43.81% in urban areas. The economic burden of cardiovascular disease on residents and society increasingly aggravated.
The report pointed out that the prevalence of cardiovascular disease in my country is in a stage of continuous increase, and it is estimated that the number of people suffering from cardiovascular disease is about 330 million.
Throughout the world, more than 18 million people die from cardiovascular and cerebrovascular diseases every year, while there are about 1.8 billion people with potential cardiovascular diseases, which means that less than 10% of patients worldwide have been effectively treated.
The main reason is that the current treatment of cardiovascular disease is still limited to the treatment of terminal symptoms.
How to intervene and treat diseases in the early stage has become a new direction of medical technology research.
The multi-directional differentiation potential and self-replication ability of stem cells provide sufficient support for the development of "people-oriented" medical technology.
The REVOVAS® vascular technology was born under such a scientific background. It can repair vascular tissue in the early stage, eradicate the disease, improve the quality of life, and bring a new treatment concept and treatment plan to the majority of patients with cardiovascular disease.
Based on the Biosynsphere® technology platform, the Blu-ray Inno stem cell technology system also provides new solutions for the early treatment of similar chronic diseases.
