Abstract
Cell therapy must be regulated as medicine.
Highlights
Cell therapy is a field that has a checkered history, which was plagued at one time or another by superstition, blatant medical malpractice, and lack of efficacies [1]
With technological advancements and a better understanding of the immune system, we are able to generate billions of T lymphocytes with defined antigen specificity, natural killer cells, as well as professional antigen-presenting cells such as dendritic cells [5]
Synthetic immunologists are especially proud of re-directing T cell antigen-specificity via enforcing the expression of chimeric antigen receptors and deleting the endogenous T cell receptor or other regulatory molecules such as program death 1 molecule (PD-1) via gene editing [6]
Summary
Cell therapy is a field that has a checkered history, which was plagued at one time or another by superstition, blatant medical malpractice, and lack of efficacies [1]. With technological advancements and a better understanding of the immune system, we are able to generate billions of T lymphocytes with defined antigen specificity, natural killer cells, as well as professional antigen-presenting cells such as dendritic cells [5]. Such a high level of enthusiasm was often further fueled by press releases and anecdotal reports of the wonder of killer cells in one form or another in animal studies or in early-phase clinical trials.
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