Blu-ray develops 3D printed vascular application clinical trials: 156 million cardiovascular patients worldwide welcome hope

On August 10th, 2016, the world's first 3D bio-printing vascular animal was announced in vivo, and Kang Yujian called it “a day to rewrite the medical history book”.

On December 11th, Blu-ray Development held the “Big Breakthrough Achievement Report of Blu-ray Yingnuo Stem Cell Application Technology”. As the CEO and chief scientist of Blu-ray Inno, Kang Yujian was still excited when he mentioned the above-mentioned major technological breakthroughs.

The success of the in-vivo experiment means that the development of Blu-ray has achieved a major technological breakthrough in solving the problem of endothelialization of artificial blood vessels following the world's first 3D biovascular printer in October last year. In this regard, Donald Thomason, president of the University of Tennessee Health Science Center, commented, "Although 3D bioprinting experiments are being carried out worldwide, the result of Blu-ray Inno is the most mature technology I have seen so far."

According to Donald Thomason, the breakthrough in the above technology has brought more imagination, "all the blood vessels and even organs of the human body will benefit from this technology." Blu-ray development said that in the next step, 3D bioprinting blood vessels will apply for clinical trials from relevant regulatory agencies. This means that 156 million patients worldwide who require artificial blood vessels and stents will welcome new treatment hopes, and an exciting breakthrough in 3D bioprinting and stem cell research applications.

A new breakthrough in medical problems in the half century

"A patient who has become ill and has a disease for a lifetime", patients with cardiovascular disease who have undergone artificial blood vessel implantation and stenting surgery should feel this deeply.

Because traditional treatment methods are difficult to form or fuse into new endothelial cells, prone to blood blockage and aging and damage, these patients often require long-term maintenance and even potential risks. Most of them will take a drug called anticoagulant for the rest of their lives to maintain the normal work of artificial blood vessels.

The problem of endothelialization of blood vessels, which has been proposed since 1952, has finally made new breakthroughs.

On December 11th, the first batch of “Thousand Talents” national special experts, the American Academy of Toxicology, and the CEO and chief scientist of Blu-ray Inno, Professor Kang Yujian, released 3D bioprints from their teams. A major breakthrough was made in the research and development of artificial blood vessel endothelialization: the world's first 3D bioprinting vascular animal was successfully tested in vivo.

For nearly 1.8 billion patients with cardiovascular disease worldwide, this marks the successful solution to the problem of endothelialization of artificial blood vessels that has plagued the clinical half-century. “This achievement is a milestone for the clinical application of stem cell technology,” Professor Kang Yujian said at the results conference.

During the 7-month animal experiment, Blu-ray Inno has performed 3D bioprinting in vivo implantation experiments on 30 rhesus monkeys. As of December 1, 2016, the results showed that the structure and function of the 3D bioprinting vascular were consistent with the experimental animal's own blood vessels. No abnormalities were found in the physiological indexes of the experimental animals, and the survival rate of the experimental animals was 100%.

Can the "printed" blood vessels function as autologous blood vessels? Kang Yujian humorously compared Blu-ray Inno's 3D bio-printing blood vessels to the "yellow-throat" in Sichuan hot pot. The elasticity and toughness can withstand "repetitive fiddling." After 21 days of growth in rhesus monkeys, the "printed" vascular morphology and tissue were essentially indistinguishable from autologous blood vessels.

Professor Kang Yujian said: "The success of in vivo experiments in 3D bioprinting blood vessels not only solves the problem of endothelialization of artificial blood vessels, but also breaks the understanding of the various cells required for adipose-derived mesenchymal stem cells to differentiate into vascular tissues." The treatment of cardiovascular disease brings new hope, opens up a new direction of stem cell research and application, and opens a new era of 3D bioprinting medicine.

It is reported that the animal experiment will continue until May 2017, and the standardization of the 3D bioprinting vascular graft procedure will be completed in the subsequent stage.

At the same time, the Blu-ray development announcement stated that after the animal's in vivo experiment, the next step of the company's 3D bio-printing blood vessels will apply to the relevant regulatory agencies for clinical trials. Blu-ray Development said that the clinical study of the project is a long-term work, mainly including Phase I to Phase III clinical trials. The general time required is 4 to 6 years, and the time required for Phase IV clinical monitoring after marketing is more than 3 years. At present, according to the results of animal experiments and related regulatory requirements, Blu-ray Development is writing, supplementing and improving clinical trial application materials.

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