LeadsBio Announces Global First Successful Implantation of Tissue-Engineered Bio-Artificial Blood Vessel in Uremic Patient

Recently, the Jinshan Branch of the First Affiliated Hospital of Chongqing Medical University successfully completed the world's first rescue of a uremic patient using a tissue-engineered enhanced biological artificial blood vessel independently developed by LEADBIO. After two years, with the support of this treatment, the patient’s body has...Biovascular grafts have surpassed the preset two-year degradation period for artificial materials, successfully achieving autologous tissue replacement and "growing" a new blood vessel within the body.Currently, the patient's dialysis treatment is proceeding smoothly, and their quality of life has significantly improved.

Seven years ago, the patient was diagnosed with uremia and since then has required approximately three hemodialysis treatments per week to sustain life. However, the long-term repeated puncture treatments have severely damaged the blood vessels in their arm, leading to a gradual deterioration of vascular condition, making it difficult to meet the ongoing demands of dialysis treatment.

For uremic dialysis patients, maintaining a clear dialysis access is crucial for long-term survival. Dialysis access is typically established by finding a suitable blood vessel in the patient’s body to serve as the pathway for hemodialysis, known as an "arteriovenous fistula." This pathway allows blood to be drawn from the patient’s body, filtered through a dialyzer to remove waste and excess fluid, and then returned to the body to sustain life.

However, the patient's original arteriovenous fistula in the limb had failed due to thrombotic occlusion, and after evaluation, it was found that the patient’s own vascular condition was poor, making it very difficult to re-establish an arteriovenous fistula. This situation once made the patient lose confidence in continuing the fight against the disease.

After consultation and analysis of the patient's condition by the vascular surgery expert team at Jinshan Hospital of Chongqing Medical University First Affiliated Hospital, it was decided to use the tissue-engineered reinforced bio-artificial blood vessel developed by LEADBIO for the patient's treatment.As the polymer fibers in the bio-vessel gradually degrade in the later stages, the patient's own cells have successfully grown into and replaced the artificial material. Currently, the structure of this new vessel remains in good condition, truly achieving tissue regeneration and repair.

It is worth noting that,The product completed animal experimental research in 2022 and successfully finished the first-in-human phase experiment at the First Affiliated Hospital of Chongqing Medical University and the First Affiliated Hospital of Zhengzhou University.Currently, the product is undergoing product registration clinical trials at multiple medical centers across China.More than 200 patients have received experimental treatment with tissue-engineered enhanced bio-artificial blood vessels, and none of them have shown signs of rejection.Further demonstrates the safety and effectiveness of LEADBIO's tissue-engineered enhanced bio-artificial blood vessels.

LEADBIO's biological artificial blood vessel, as the world's only medical product currently combining polymer materials with decellularized matrix, can be applied in AV graft (AVG) surgeries for hemodialysis patients and other fields of vascular disease treatment. The successful development of this technology not only fills the market gap for tissue-engineered blood vessels in China but also...For blood dialysis, peripheral vascular disease, heart bypass surgery, organ transplantation and other procedures urgently requiring artificial vessels for fistula creation, replacement, and bypass.For the treatment of patients, a safe and effective artificial blood vessel solution is provided. This breakthrough marks the progress of artificial blood vessel technology in China and has profound significance for improving the level of medical technology in China and promoting the sustainable development of the medical cause.

In vascular surgery, artificial blood vessels play a pivotal role. They not only serve as replacements for many severely narrowed or occlusive vessels but also are crucial in aortic replacement surgery, peripheral vascular repair and transplantation, as well as arteriovenous fistula creation for hemodialysis.

Currently, artificial blood vessel technology has shown a high level of maturity in the field of aortic vessel replacement, and the arteriovenous fistula market occupies the largest share of the artificial blood vessel market.

According to the "Research Report on the Global and Chinese Artificial Vessel Industry and the 14th Five-Year Plan Analysis," the global artificial vessel market size reached 23.5 billion yuan in 2020 and is expected to reach 31.8 billion yuan by 2027. As a populous country, China also has a strong demand for artificial vessels. In 2020, the domestic artificial vessel market size exceeded 3 billion yuan (calculated based on terminal prices). With the intensification of global aging, continuous advancements in artificial vessel technology, and constant innovation in medical methods, it is expected that China's overall artificial vessel market will...It will maintain an average annual growth rate of over 15% in the next five years.By 2025, the market size is expected to reach nearly 4 billion RMB.

Despite significant clinical demand, the market for artificial blood vessels in China is largely reliant on imports. Most of the approved domestically produced products use materials such as polyester and polytetrafluoroethylene. Due to limitations in material properties, production technology, and clinical outcomes, many patients face challenges in using these artificial blood vessels for treatment. For instance, traditional polymer-based artificial blood vessels often lack biocompatibility and regenerative capabilities, leading to severe issues like blood clotting, thrombosis, and vascular blockages.

LEADBIO's self-developed tissue-engineered enhanced biological artificial blood vessel has broken this dilemma.

It is reported that LEADBIO has overcome technical challenges and bottlenecks in multiple aspects such as production processes, material selection, fiber scaffold optimization, and decellularization processes, adoptingSmall-Caliber Artificial Blood Vessel Extracellular Matrix + Polymer Composite Structure Approach“Skeletal Acellular Vessel” (SAV), innovativelyCombination of Artificial Polymer Materials and Natural Bio-based Materials, high technical barriers.

The artificial blood vessel is made byPolymer fiber scaffold and animal extracellular matrix composition, implanting the fiber scaffold subcutaneously in animals for a period of cultivationAfterward, the animal tissue fully fills the framework pores, and after removal and processing through decellularization, a biologically engineered blood vessel product composed of composite extracellular matrix and fiber framework is obtained.The product combines excellent mechanical properties with regenerative activity. After the blood vessel is implanted in the body, it not only provides sufficient mechanical support but also promotes the growth of the body's own cells and blood vessel regeneration as the material degrades, making endothelialization of artificial blood vessels possible.

In the process of researching and producing this artificial blood vessel, LEADBIO optimized the product in multiple aspects.

InVascular MaterialsIn terms of material selection, the team fully considered the opinions of doctors and comprehensively evaluated factors such as degradation rate, mechanical properties, and biocompatibility, ultimately choosing PCL (polycaprolactone) as the fiber scaffold material. InProcessingIn China, by strictly controlling the spinning conditions, finely adjusting the fiber parameters, and optimizing the effects of cell migration and vascular regeneration.Decellularization ProcessAbove, innovative methods are adopted to ensure complete removal of cells while retaining active substances and avoiding structural changes.

This time, the successful application of this artificial blood vessel product in arteriovenous graft (AVG) for hemodialysis patients has also raised hopes for its future expansion into the treatment of other vascular diseases.

From the successful development of seamless artificial blood vessels in the early 1950s to the continuous application of various new materials and advanced processing technologies in the manufacturing of artificial blood vessels, artificial blood vessel products have gradually improved in key indicators such as biocompatibility, plasticity, and biomechanics. An increasing number of vascular diseases can now be treated with artificial blood vessels. However, the preparation of small-diameter blood vessels, particularly those with a diameter of less than 6mm, remains a challenge in the global market. Not only are the requirements for technology and material selection more stringent, but the demands for biocompatibility and anticoagulation are much higher compared to large-diameter blood vessels. The fields of polyurethane materials, tissue engineering, and small-diameter artificial blood vessels involve high technical barriers and significant R&D difficulties, resulting in very few participants.

The reason why LEADBIO has been able to achieve breakthroughs in this field is due to the company's technical accumulation on one hand, and the close cooperation of the team with industry, academia, research, and medical sectors on the other.

The founder of the company, Kong Deling, is a professor and doctoral supervisor at the College of Life Sciences of Nankai University, a recipient of the National Science Fund for Distinguished Young Scholars, the leader of the Ministry of Education's innovation team, and the head of the innovative research group of the National Natural Science Foundation. He mainly focuses on the preparation of small-caliber artificial blood vessels, active hydrogels, stem cell engineering, nanobiomaterials, and their application in treating ischemic diseases, tissue injury repair, and regeneration. Meanwhile, LEADBIO has a research and development team composed of postdoctoral fellows, doctoral students, and master’s students. The team's accumulated theoretical research and practical experience in academia provide support for the company's technological innovation and product development.

In addition, the company actively collaborates closely with research teams from industry, academia, research, and medical fields to optimize and validate cutting-edge key technologies. This collaborative model ensures that the company can continuously produce the latest scientific research achievements, providing support for innovative technology development and driving the continuous upgrading and iteration of products.

It is precisely based on the in-depth exploration of fundamental research that LEADBIO has been able to continuously advance in the materials, processes, and performance of bio-based artificial blood vessels. After completing fundamental research and technological innovation, LEADBIO proceeds to validate and scale up the transfer and transformation of technical achievements, ensuring that these achievements can be smoothly converted into actual products to meet market demands.

Because of this, since its establishment in 2019, LEADBIO has successfully overcome technical challenges by leveraging its R&D capabilities, innovative strength, and industrialization capacity, achieving the world's first successful treatment of a uremic patient with a tissue-engineered enhanced bio-artificial blood vessel.

In the future, LEADBIO will further expand its product line to achieve comprehensive product coverage.Peripheral vessels, traumatic vessels, and artificial vessels and patches used in coronary artery bypass surgeryIn multiple fields, while continuously exploring clinically urgent problem products, promoting product innovation and R&D progress.

For more content related to the original text, please click on the following link to read:Global First! Chongqing Doctor Helps Patient "Grow" New Blood Vessels