Cryopreservation of Complex Systems: The Missing Link in the Regenerative Medicine Supply Chain

Transplantation can be regarded as one form of “antiaging medicine ” that is widely accepted as being effective in extending human life. The current number of organ transplants in the United States is on the order of 20,000 per year, but the need may be closer to 900,000 per year. Cadaveric and living-related donor sources are unlikely to be able to provide all of the trans-plants required, but the gap between supply and demand can be eliminated in principle by the field of regenerative medicine, including the present field of tissue engineering through which cell, tissue, and even organ replacements are being created in the laboratory. If so, it could allow over 30 % of all deaths in the United States to be substantially postponed, rais-ing the probability of living to the age of 80 by a factor of two and the odds of living to 90 by more than a factor of 10. This promise, however, depends on the ability to physically dis-tribute the products of regenerative medicine to patients in need and to produce these prod-ucts in a way that allows for adequate inventory control and quality assurance. For this pur-pose, the ability to cryogenically preserve (cryopreserve) cells, tissues, and even whole laboratory-produced organs may be indispensable. Until recently, the cryopreservation of or