Apligraf

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Apligraf is a synthetic skin created from harvested foreskins.[1] It is FDA approved,[2] and it is made and sold by Organogenesis, which a corporation based in Canton, MA. Novartis Pharmaceuticals Corp. has global marketing rights to Apligraf.

Apligraph Oral

Organogenesis is presently seeking FDA approval for Apligraph Oral, a foreskin-derived product for the "treatment of surgically treated gingival and alveolar mucosal surface defects in adults."[3]

Sponsor slides: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/cellulartissueandgenetherapiesadvisorycommittee/ucm284480.pdf

References

  1. ↑ REFweb Apligraf: How Is It Made?, Organogenesis. Retrieved 6 March 2011.
    Quote: Human keratinocytes and fibroblasts are derived from neonatal foreskins
  2. ↑ REFweb Apligraf, Organogenesis. Retrieved 6 March 2011.
    Quote: Apligraf® is the first bio-engineered cell based product to receive FDA approval (in 1998).
  3. ↑ REFnews (error)."November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript", FDA. Retrieved 20 December 2011.
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