| 摘要 |
H:/amtJlnav<oeo/NRPobl/DCC/~ATS949~45_Ldoex-2/6/0H The invention provides improved methods for cell therapy. In particular, the invention provides therapeutic compositions of enhanced hematopoietic stem and progenitor cells having improved engraftment and homing properties, and methods of making the therapeutic compositions. The invention further provides methods of improving the efficacy of hematopoietic stem and progenitor cell transplantation including transplanting the therapeutic composition to subjects in need of hematopoietic system reconstitution. In addition to the tests discussed above, another important aspect of evaluating the final product is potency testing. Potency testing involves the quantitative measure of biological activity of a product. The biological activity should describe the ability of a product to achieve a defined biological effect. The biological activity measured should be closely related to the product's intended biological effect and ideally, it should be related to the product's clinical response [2-1_L]. Measurement of the potency of a product is not the same as measuring clinical efficacy. Rather, it is a means to control product quality. Potency assays for cellular products usually take a considerable amount of time to develop. Generally, the development of potency assays is progressive and begins during preclinical and early clinical development. A potency assay should be validated and already in place prior to phase III clinical trials involving a specific cellular therapy [9, 1]. |
