FDA mandates
Karl - I did find something that may be of interest in response to your question. It is in Steenblock and Payne's book, "Umbilical Cord Stem Cell Therapy". The following was taken from there:
Q. What is the current status of FDA approval for stem-cell treatments?
A. The FDA has not approved embryonic stem-cell treatments for any disease or condition. However, bone marrow and other sources of adult stem cells have been approved for about eighty-six diseases. And cord blood--but not pure umbilical-cord stem cells--is allowed by the FDA for certain hematopoietic diseases such as leukemia.
The National Institutes of Health (NIH) and private companies are funding research, but a great deal of the research is focused on working out the basic biology in lab animals, so progress is slow. And although several state governments have passed legislation to actively encourage stem-cell research, these laws do not mean that physicians in these states can give umbilical-cord blood or isolated stem cells to patients in need (outside of approved conditions or as part of government-sanctioned clinical trials). Federal law is supreme above state law, so even if a state were to pass a law permitting medical doctors and osteopathic physicians (D.O.) to give stem cells to their patients, this statue would surely be struck down at the federal level.
It goes on to state the the FDA has a legal mandate to protect medical consumer's health and welfare. Since embryonic stem-cell therapy is truly a "vast undiscovered country" in terms of efficacy and long term safety, the FDA is careful to enforce restrictions and regulations that keep it confined to the lab or the research center until it can be proven safe and effective. The Canadian Health Ministry has a similar policy The sad part is that this may be true for embryonic stem cells, but umbilical cord stems cells have been used for more than 40 years, they point out, with virtually no secondary illness or complications.