Nowhere, apparently, was there any authentication of whether the stem cells actually were stem cells, or where they had come from.
Stem cells most often, but not always, came from the patient's own bone marrow. Others reportedly came from aborted fetuses, animal tissues or donor tissues.
Web site information tended to be heavily skewed toward the alleged benefits of the process, and away from its risks. And the price? According to the paper, when advertised, the average cost of these therapies -- excluding airfare and accommodation -- was $21,500.
The new guidelines are meant to guide research toward what is practical and responsible, Hyun said. Previous scientific guidelines and regulations have regulated human-subjects research and clinical research in general, as well as gene transfer research, but not stem cell research, which poses a number of independent issues.
"Most of the time, stem cell products are presenting entirely novel products that are unpredictable in humans," Hyun said. "Unlike drugs, you can't just create a batch and put them on the shelf and expect they will be the same. We need uniform quality control and manufacturing. And if they're embryonic or pluripotent stem cells, they could form unwanted tissues or tumors. So, we have to be very careful about following up and monitoring patients."
Accordingly, the guidelines, written by a task force of stem cell specialists from 13 countries, addressed issues of ethical review, quality and
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