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Stem cells represent an unlimited source for cell therapy (1), and considerable efforts have been made to overcome barriers to introducing this revolutionary therapy into clinical practice. Briefly, the following actions must be taken: 1 ) design in vitro differentiation strategies to generate either mature postmitotic β-cells or β-cell progenitors that may be safely implanted into the host (e.g., without uncontrolled proliferation), 2 ) devise selection methods to produce a pure β-cell population, 3 ) validate standard characterization protocols to determine the real differentiation stage of the cells ready to be transplanted, 4 ) obtain encapsulation devices to implant the cells, 5 ) develop preclinical controls in representative animal models, and 6 ) define cell-host interactions (for a recent review see ref. 2).A breakthrough for in vitro differentiation and selection strategies was reported in Diabetes when it was shown for the first time that the process was doable (3). A combination of directed differentiation and gene-trapping strategies succeeded in manufacturing insulin-producing cells derived from rodent embryonic stem cells that normalized blood glucose when implanted into streptozotocin (STZ)-induced diabetic mice. Further reports improved the system by introducing new differentiation strategies, such as inhibiting sonic hedgehog or selecting cells expressing a gene also expressed in islet progenitor cells (Nkx6.1) (4). It was also shown that differentiated cells do not form teratomas (4,5) and they mature 30 days after transplantation (4). Subsequently, in vitro differentiation protocols for human …

A Role for the Host in the Roadmap to Diabetes Stem Cell Therapy