The transition from bench to bedside: lessons learned in the creation of a new T-cell product for the clinic.
While the technology of translational research is sometimes considered a poor relation to 'basic science', it has become a central focus of work to turn exciting new concepts into practical therapies. Here we use the example of selective T-cell depletion of allografted lymphocytes to illustrate the problems of scale-up, reproducibility, sterility, safety and regulatory concerns encountered during the bench to bedside process.
Barrett
J
J
Stem Cell Allo-transplantation Section, Hematology Branch NHLBI, NIH Rockville Pike, Bethesda, Maryland 20892, USA.
Solomon
S
S
D000368:Aged; D002986:Clinical Trials as Topic; D006086:Graft vs Host Disease; D006801:Humans; D008875:Middle Aged; D012106:Research; D033581:Stem Cell Transplantation; D013601:T-Lymphocytes / Q000276:immunology* / Q000502:physiology