Does the donor pose a risk of transmitting infectious or genetic diseases?
Does cell or tissue processing pose a risk of contamination or damage? What are the types of cells, and what are the purity and potency of cells in the final product? Will the product be safe and effective in vivo? Does the Donor Pose a Risk of Transmitting Infectious or Genetic Diseases? Although the use of a person’s own cells and tissues does not require screening and testing for communicable diseases,20 such analysis is required for transplantation between two people.21,22 Additional screening and testing are required for certain tissues that pose a particular risk of disease transmission, such as viable leukocyte-rich23 or reproductive24 cells or tissues. Gametes “donated by a sexually intimate partner of the recipient for reproductive use”25 and in certain other instances26 are excluded from screening and testing requirements. Thus, in the case of excess embryos from in vitro fertilization (IVF) clinics, which serve as the primary source of human embryonic stem-cell lines, the ga
