Complicating matters is that common combinations of versions of HLA proteins vary considerably within ethnic or racial groups, and quite dramatically between racial groups. No information is available on the federally approved cell lines' particular combinations of HLA proteins, but the lines' small number and their derivation from embryos created for reproductive use indicate their HLA diversity is likely to be woefully inadequate.
Instead, researchers will need access to a group of human ES cell lines that match as many people as possible. Because there would be limited resources for establishing such a "bank" of ES cell lines and because of concerns for early human life, the panel carefully considered how to optimize Americans' "biological access" to future therapies with these cells.
"The question for the panel was one of justice, justice with respect to which groups are likely to benefit and which groups are likely to lose if research proceeds in certain ways," says Faden. "We asked: If not everyone can benefit because of biological factors, what is the fairest way to design future trials and therapies?"
For fast clinical research, the panel concluded unanimously that researchers should establish a "bank" with the fewest number of cell lines that reflect the most Americans. Because of the country's demographics, the lines would match mostly white Americans, but several HLA types common in other ancestral groups should be included so research can address diseases that occur more frequently or have different characteristics in non-white groups. This would be the fastest way to see whether the cells' clinical potential is worth pursuing, the panel concluded.
"The faster the cell-based therapies can be proven safe and effective, the
faster everyone can benefit," says Faden. "At the
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Contact: Joanna Downer
jdowner1@jhmi.edu
410-614-5105
Johns Hopkins Medical Institutions
10-Nov-2003