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Engineered tracheas, corneas and arteries enter clinical testing

Nature Biotechnology volume 32, pages 303–304 (2014)Cite this article

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Organogenesis was one of the first companies to make commercial headway in the area of cell-based regenerative therapeutics, winning FDA approval in 1998 for Apligraf, and more recently for Gintuit. Although cell-based, these patches to repair skin and gum, respectively, actually turn out be a temporary presence that ultimately disappears from the recipient's body. “If you take a biopsy of the wound after about four to six weeks, you will not find any residual Apligraf,” says Organogenesis CEO Geoff MacKay. “It's a temporary biological stimulus that induces the patient to heal themselves.” Wound healing remains one of the most active sectors of the industry (Tissue Eng. Part B Rev. 18, 155–166, 2012).

Off-the-shelf products typically use donor allogeneic cells and generally appear to be nonimmunogenic. But in tissue reconstruction, autologous cells derived directly from the patient are seen as preferable. Sanofi's MACI (matrix-induced autologous chondrocyte implant), a product to treat cartilage defects, consists of a collagen scaffold fashioned from an individual's own cartilage-forming chondrocytes, seeded onto a supportive pig collagen membrane, which is then surgically applied to the joint. It is currently commercially available in Europe and Asia but not the US.

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Change history

  • 29 May 2014

    In the version of this article initially published, the article incorrectly stated there was one case of rejection in a phase 1 trial of corneal implants, when there were none. There was one case of rejection in the control group that received donor corneas. The error has been corrected in the HTML and PDF versions of the article.

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    Michael Eisenstein

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  1. Michael Eisenstein
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Eisenstein, M. Engineered tracheas, corneas and arteries enter clinical testing. Nat Biotechnol 32, 303–304 (2014). https://doi.org/10.1038/nbt0414-303a

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