There is still room for improvement. Obtaining FDA approval is still a major hurdle, in part because cells obtained from different people may not behave alike and because recipients can have varying responses to the same kind of implant. Such unpredictability can make it difficult for the FDA to determine that a given engineered construct is safe and effective. Further research is therefore important to measure and understand variations between individuals and to account for them in clinical trials that study tissue-engineered products. And future business models must include the extensive costs that will be associated with this work.
Still, armed with recent insights into how tissues develop and how the body repairs itself naturally, tissue engineers are now aiming to create second-generation products that are closer mechanically, chemically and functionally to their biological counterparts than ever before. Even in today’s strained economic climate, we expect that research into nanotechnology, stem cell biology, systems biology and tissue engineering will soon converge to yield fresh ideas for devising the sophisticated organ substitutes needed by so many people today.
Ali Khademhosseini is an assistant professor at Harvard-MITs Division of Health Sciences and Technology and at Harvard Medical School. Since earning his Ph.D. under Langers direction, Khademhosseini has focused his research on developing microscale and nanoscale technologies to control cellular behavior for tissue
engineering and drug delivery. Joseph P. Vacanti is surgeon in chief at Massachusetts General Hospital for Children, a professor at Harvard Medical School, and deputy director of the Center for Regenerative Medicine at Massachusetts General Hospital. Robert Langer is an Institute Professor at the Massachusetts Institute of Technology and the most cited engineer in history. Langer and Vacanti pioneered tissue-engineering research
together and wrote about their fledgling field in the September 1995 and April 1999 issues of Scientific American.
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