The clinical need and historical approaches to tissue engineering as applied to regenerative medicine are introduced, along with comments on activities in this field around Australia, and then the huge advances for tissue culture studies are discussed (Part A). Combinations of human stem cells and new approaches for generating bioscaffolds present great opportunities for in vitro studies of basic biology and physiology, drug testing and high throughput screening for the pharmaceutical industry, and the advanced tissue engineering of organs and devices. The future here is bright. The major obstacles arise with in vivo application of these bioengineering advances using animal models and humans (Part B), and the complexity of living tissues and the challenges of increased scale required for clinical translation to the large human situation are first discussed. While clinical success seen with implantation of acellular bioscaffolds (with population by host cells) is likely to expand for human use, the major challenge relates to (generally) low survival in vivo of (donor or autologous) cells that are expanded and grown in tissue culture before implantation into the living body. Another major challenge is revascularisation of implanted tissues/organs at the human scale. The innovative approaches and rapid advances in tissue bioengineering hold great promise for overcoming these major obstacles and extending the clinical applications of these technologies.