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Inherent risks associated with manufacture of bioengineered ocular surface tissue

Schwab, Ivan R., Johnson, Nigel T., & Harkin, Damien G. (2006) Inherent risks associated with manufacture of bioengineered ocular surface tissue. Archives of Ophthalmology, 124(12), pp. 1734-1740.

Abstract

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 1 or more animal-derived products and an overlapping 95% used 1 or more donor human tissues. Consideration of risks reveals a very low probability of potential harm but a significant risk of disability or death if such an event were to occur. Details of ethics approval, patient consent, and donor serologic test results were not consistently provided. No references were made to risk assessment or to codes of manufacturing and clinical practice. CONCLUSION: While a degree of risk is associated with bioengineered ocular surface tissue, investigational reports of this new technology have yet to address issues of risk management and regulatory oversight. CLINICAL RELEVANCE: Attention to risk and codes of manufacturing and clinical practice will be required for advancement of the technology. We suggest the adoption of international standards to address these issues.

Impact and interest:

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27 citations in Web of Science®

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ID Code: 8515
Item Type: Journal Article
Additional Information: For more information, please refer to the journal’s website (see hypertext link) or contact the author. Author contact details: d.harkin@qut.edu.au
Additional URLs:
ISSN: 0003-9950
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > IMMUNOLOGY (110700) > Transplantation Immunology (110708)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > OTHER MEDICAL AND HEALTH SCIENCES (119900) > Medical and Health Sciences not elsewhere classified (119999)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > CLINICAL SCIENCES (110300) > Infectious Diseases (110309)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > CLINICAL SCIENCES (110300) > Surgery (110323)
Australian and New Zealand Standard Research Classification > PHILOSOPHY AND RELIGIOUS STUDIES (220000) > APPLIED ETHICS (220100) > Bioethics (human and animal) (220101)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > OPTOMETRY AND OPHTHALMOLOGY (111300) > Vision Science (111303)
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Divisions: Past > QUT Faculties & Divisions > Faculty of Science and Technology
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Research Centres > Science Research Centre
Copyright Owner: Copyright 2006 American Medical Association
Deposited On: 09 Jul 2007
Last Modified: 29 Feb 2012 23:27

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