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. "Apligraf: How Is It Made?". Organogenesis. http://www.apligraf.com/professional/what_is_apligraf/how_is_it_made/. Retrieved 2011-03-06. "Human keratinocytes and fibroblasts are derived from neonatal foreskins" 
  2. "Apligraf". Organogenesis. http://www.organogenesis.com/products/bioactive_woundhealing/apligraf.html. Retrieved 2011-03-06. "Apligraf® is the first bio-engineered cell based product to receive FDA approval (in 1998)." 
  3. "November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript". November 2011. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM284112.pdf. Retrieved 2011-12-20. 
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