Data obtained preclinical studies of the liver, created by the method of 3D-bioprinting

NovoGen Bioprinter, which is used to print the liver

Organovo presented the data of preclinical studies of an artificial human liver created by organic 3D printing . The results were announced at the conference TERMIS-Americas , which was held December 11-14, 2016 in San Diego. Tests for the first time in practice showed the survival of artificial human tissue and its stable functioning in the mouse body. Evidence has been obtained for the stable formation of blood vessels in the liver. The study showed the most important thing: human proteins are actually produced in an artificial liver and key enzymes of human metabolism are manifested.

This is an important step to the beginning of full-fledged clinical trials, and then commercial 3D printing of organs in unlimited quantities - for installation by the needy.

During the tests, fragments of human liver tissue were implanted into the liver of an immunodeficiency white mouse NOD / SCID mutant , specifically bred for such experiments. The tissue consists of human hepatocytes (cells of the liver parenchyma) and individual non-parenchymal cells. The functioning of 3D-printed tissue of human liver was observed in human albumin, alpha-1-antitrypsin and fibrinogen circulating in the blood of the mouse for 7-28 days after implantation. A histological evaluation of implanted therapeutic tissue showed the preservation of cell organization for 28 days after implantation with healthy manifestation of key human metabolism enzymes that are associated with congenital metabolic defects, such as fumarylacetoacetate hydrolase deficiency (FAH) and ornithine transcarbamylase deficiency (OTC). The tissues of the human liver behaved quite the way it was supposed to. Throughout the period of preclinical testing, the liver tissue remained intact and was well received by the body of animals.
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The results of preclinical studies support Organovo’s plan for 3D printing of artificial liver for therapeutic use.

Artificial liver will be an important achievement of modern biomedicine and 3D printing. First of all, it will help people suffering from congenital metabolic diseases listed above, and acute chronic liver failure.

The liver is one of the most deficient organs for transplantation. Every day dozens die because of liver failure, because they did not get an organ for transplantation. 3D printing can forever forget about this organ deficit. Not surprisingly, liver bioprinting Organovo entered the list of 10 most important discoveries of 2016 according to The Scientist.


Growing the human liver organoid from induced pluopotent stem cells. Illustration: scientific work published on October 7, 2015 in the journal Nature

“Our preclinical data shows rapid vascularization [the formation of new blood vessels] and tissue engraftment,” said Dr. Eric David David, Chief Strategic Director and Executive Vice President for Preclinical Development of Organovo, - and evidence of liver function and longevity printed by the method of 3D bioprinting for several weeks. Most importantly, we have obtained evidence of stable production of human proteins in the liver and the manifestation of key enzymes of human metabolism. ”

Within three to five years, Organovo is going to complete all the necessary tests and submit an Investigational New Drug (“IND”) application for a new drug to the FDA Office for Food and Drug Administration. After approval of the FDA application, nothing will prevent the drug from entering the US market, and soon other countries.

For patenting human liver cells created in this way, Organovo entered into a licensing agreement with Uniquest . Probably, Organovo itself will concentrate on scientific research and will receive royalties, and Uniquest bioengineers will grow fabric for sale.


Organovo has also begun to conclude distribution agreements in advance with companies that will sell the printed liver in other countries. For example, in Japan , Cosmo Bio will become the official distributor. Liver vendor Organovo in Russia is not yet defined.

For more information on the Organovo artificial liver, see also the scientific article "Kidney organoids from human iPS cells contain multiple lineages and model human nephrogenesis" published October 7, 2016 in the journal Nature (doi: 10.1038 / nature15695, pdf ).