Cell therapy (also called cellular therapy or cytotherapy) is therapy in which cellular material is injected into a patient, this generally means intact, living cells. For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy.
The success of a cell therapy clinical trial rests on the ability to deliver a viable, potent product. This positive end-result is directly attributable to the strategy in place and the supporting processes. A reliable cell therapy logistics strategy is imperative to ensuring your biopharmaceutical products, therapeutic materials and patient biological samples remain viable from the point of manufacture to the final clinical site delivery.
What are the risks of stem cell therapy?
- You can find information about risks of stem cell therapy at www.va.gov
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- Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century – www.nam.edu
Cell Therapies Video
Development of new cell therapies therefore places high demands on the hospital organization, as well as on employee expertise in drug development. To further complicate the situation, the current regulatory framework is not fully adapted to cell therapies; for example, ambiguity exists as to whether or not cells should be classified as drugs.