Author Archives: Nicole M. Provost, PhD

Standards for Ancillary Materials Used in Cell- and Tissue-Based Therapies

Cell- and tissue-based therapies are being used increasingly to treat many diseases for which currently no other adequate treatment options are available. These products contain human or animal cells that can replace, regenerate, or augment a recipient’s diseased, dysfunctional, or injured cells, tissues, or organs. Cells or tissues might be unmanipulated, or their biological characteristics can be altered ex vivo before administration of the final product to patients. Examples of cell therapies range from traditional blood transfusions to recent approaches…