Hypothermic Storage and Cryopreservation Successful Short- and Long-Term Preservation of Cells and Tissues

Early successes of cell therapy in applications such as repair of diseased hearts (1) and treatment of Type 1 diabetes (2) support the notion that the use of cells and tissues to treat disease states is one of the most promising avenues in contemporary medical treatment. In part, many cell therapy applications evolved indirectly from the launch of tissue engineering ventures that led to commercial development of engineered products such as skin and cartilage. Cell and tissue therapy has showcased its potential in medicine through recent clinical trials and is maturing under the new rubric of regenerative/reparative medicine. The emergence of celland tissuebased technologies and the move toward a global marketplace are creating a demand for new technologies that allow worldwide shipment of such products while maintaining their viability or function — a concept referred to as biological packaging (3). Our research team has previously reported on how BioHeart Inc. used improved biological packaging methods to launch its successful cellular cardiomyoplasty clinical trials with European patients while using cell production laboratories in the United States (3). Briefly, a patient biopsy is shipped hypothermically (~4 °C) from Europe to the United States. Myoblasts from the sample are isolated and expanded, and the final product of myoblasts is shipped back in hypothermic suspension to a surgical suite in Europe, where they are injected as a cell slurry directly into damaged heart tissue. This transcontinental shipment required hypothermic preservation solutions that maintain viability and function of the cells following sequential storage intervals for transport that approach a week in duration. In the field of tissue engineering, limited success was recently reported on the development of engineered corneas (4). Ten million people worldwide suffer from corneal blindness; many reside in the Himalayas and other countries at high altitude, where ultraviolet light can be the catalyst for opacities. If optically clear, transplantable, engineered corneas were to be developed, how might such tissues be transported to these remote regions where several weeks or more of hypothermic storage may be necessary? This example also demonstrates the future importance of biological packaging and preservation in the global marketplace. The principles governing the development of effective biological packaging necessitate an understanding of state-of-the-art hypothermic storage and cryopreservation: the two standard approaches currently used for preserving cells and tissues for PRODUCT FOCUS: CELLS AND TISSUES