Table 2.

Relevant criteria for clinical cell therapy in WD

Criterion	Comments
Availability of subjects with well-defined and appropriately documented clinical disease	Needs establishment of patient registries and infrastructure for undertaking cell therapy
Well-characterized donor cells, including isolation and banking under cGMP conditions	Academic–private partnerships and greater funding for clinical trials will be helpful
Defined protocols for cell delivery, dosing, and hepatic targeting	Optimization required of specific protocols for clinical studies. Unified protocols for multicenter studies will be most effective
Persistence of transplanted hepatocytes should be indefinite	Allograft rejection and inflammation requires better controls and less toxic drugs
Liver replacement and repair should be quantifiable	Novel noninvasive assays for evaluating efficacy of cell therapy are desirable