This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on Web of Science (7)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Neurology  • Statistics and Research Methods  • Transplantation, Other  • Facial Plastic Surgery  • Biomaterials and Implants  • Alert me on articles by topic  Social Bookmarking   What's this?

Ivan R. Schwab, MD; Nigel T. Johnson, BAppSc(Med&AppBiotech); Damien G. Harkin, PhD

Arch Ophthalmol. 2006;124:1734-1740.

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.

Author Affiliations: Department of Ophthalmology, University of California, Davis (Dr Schwab); Queensland Eye Institute, South Brisbane (Drs Schwab and Harkin) and Institute of Health and Biomedical Innovation, Queensland University of Technology (Drs Schwab and Harkin and Mr Johnson), Australian Red Cross Blood Service (Dr Harkin and Mr Johnson), and Tissue Therapies Ltd (Dr Harkin and Mr Johnson), Brisbane.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?