Inherent risks associated with manufacture of bioengineered ocular surface tissue.

  title={Inherent risks associated with manufacture of bioengineered ocular surface tissue.},
  author={Ivan R. Schwab and Nigel T Johnson and Damien G. Harkin},
  journal={Archives of ophthalmology},
  volume={124 12},
OBJECTIVE To review the potential health risks associated with bioengineered ocular surface tissue, which serves as a bellwether for other tissues. METHODS All clinical trials using bioengineered ocular surface tissue published between July 1, 1996, and June 30, 2005, were reviewed with respect to materials used and statements of risk assessment, risk remediation, adverse events, manufacturing standards, and regulatory oversight. RESULTS Ninety-five percent of investigational protocols used… CONTINUE READING

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