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Das Bioprinting Unternehmen Organovo mit Sitz in Kalifornien präsentiert Daten und Ergebnisse aus den ersten vorklinischen Studien mit Tiermodellen auf dem TERMIS-Americas Meeting in San Diego.
Organovo hat das menschliche Lebergewebe aus seinem 3D Bioprinter in die Leber von NOD/SCID Mäusen implantiert. Die Ergebnisse der präklinischen Studien zeigen schnelle Gefäßneubildung und Anwachsen und liefern Beweise über die Funktionalität und Haltbarkeit über mehrere Wochen.
Einer der bedeutendsten Fakten ist jedoch die Bildung von wichtigen menschlichen Leberproteinen im tierischen Blutkreislauf sowie der Nachweis von bedeutenden menschlichen Stoffwechselenzymen. Vor allem die Präsenz der Enzyme ist bedeutend für die Behandlung von angeborenen Stoffwechselkrankheiten.
Auszug aus der Pressemeldung:
Organovo implanted its 3D bioprinted human liver tissue patches onto the livers of NOD/SCID mice. The tissue was composed of human hepatocytes and select non-parenchymal cells. Function of the 3D bioprinted human liver tissue patches was seen via detection of human albumin, alpha-1-anti-trypsin and fibrinogen in the circulating blood of the mice as early as seven days and for at least 28 days post-implantation. Histopathologic evaluation of the implanted therapeutic tissue revealed retention of the bioprinted cellular organization through 28 days post-implantation, with robust staining for key human metabolic enzymes associated with inborn errors of metabolism, such as Fumarylacetoacetate Hydrolase (FAH) deficiency and Ornithine Transcarbamylase (OTC) deficiency. The tissues remained intact on the animal liver and were well tolerated by the animals. Taken together, these data support further preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use.
Focusing first on acute-on-chronic liver failure and pediatric inborn errors of metabolism, both indications where a bioprinted liver patch may show therapeutic benefits, Organovo intends to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its therapeutic liver tissue in three to five years. The total addressable market opportunity for these initial indication areas exceeds $3 billion in the U.S. As appropriate, Organovo will pursue breakthrough therapy designation, clinical development outside the United States, and other opportunities to help accelerate time to market.
