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Are Autologous Stem Cells Legal?

By Health_Freedoms at Dec. 16, 2015, 6:59 p.m., 22260 hits

by Daniel F. Royal, DO, HMD, JD

In 2005, I worked with State Senator Michael Schneider, a member of the Commerce and Labor Committee, to draft legislation that would specifically permit the use of autologous stem cells in the State of Nevada. This legislation eventually became law. It was placed in Chapter 629 of the NRS, which is known as the “Healing Arts Generally,” so that this legislation affects all of Nevada’s state medical boards. Today, Nevada is the only state that has such a law.

In short, Nevada Revised Statutes (“NRS”) 629.300 to 629.390 provide for the banking, administration, compounding, and importation of “nonembryonic stem cells.” Moreover, NRS 629.340 states that “a state professional board, shall not…regulate the activities authorized by NRS 629.300 to 629.390, inclusive; or Take disciplinary action or impose civil or criminal liabilities or penalties against a person for engaging in an activity authorized by NRS 629.300 to 629.390, inclusive.”

In addition, health practitioners also have some federal protection for the use of autologous stem cells. In 21CFR 1271.10, the Food and Drug Administration (“FDA”) states that that stem cells are regulated by the Public Health Services Act, and not the FDA, so long as such cells are not more than “minimally manipulated” and they are “intended for homologous use only.”

Nevertheless, when using autologous cells as a treatment modality in one’s medical practice an informed consent should also be used. Here, the patient will be informed of the procedure itself along with its potential risks. Examples of such risks for using autologous stem cells could include the following:

•pain at blood draw or extraction site;
• light-headedness from blood draw or extraction;
• swelling at intravenous infusion site;
• infection at injection or extraction site (rare); and/or
• “Herxheimer Reaction” (incl. headache, nausea, diarrhea, chills, fever, etc.) from reintroduction of
autologous cells, which is temporary and usually resolves within 24-48 hours.

Although there are ICD-10 codes for the donation (Z52.011) and transplant (Z94.84) of autologous stem cells, as well as CPT Codes for autologous hematopoietic harvesting (38206) and autologous hematopoietic transfer (38215), most insurance companies consider treatment with stem cells to be “experimental.” Consequently, a patient’s insurance is not likely to pay for the procedure. Thus, the patient will also need to be informed they will need to cover the cost of the treatment themselves.

Nevertheless, the use of non-embryonic stem cells is increasingly becoming a primary focus of researchers and clinicians in the stem cell space. This is partly because the use of embryonic stem cells continues to face moral challenges from many governments, doctors, etc. and partly because the use of non-embryonic stem cells has legal support. However, one problem with non-embryonic stem cells has been isolating and expanding their numbers in human tissue. Accordingly, there is a need for developing methods to expand, harvest, reconstitute and reintroduce the non-embryonic stem cells into subjects for use in treating diseases.

All this aside, using pluripotent cells obtained from autologous sources for tissue regeneration is a promising new direction in the search for remission in patients with disease conditions where mechanisms are not always fully understood (e.g., COPD, Parkinson’s, etc.). These pluripotent cells are a potential source for cell replacement as their pluripotency allows them to differentiate into various types of cells that can replace old, damaged, and/or dying cells. When this occurs, it is believed that a disease process may be stopped in its progression and begin to reverse. Therefore, we have a new modality to improve the quality of life for those patients who receive treatment with autologous non-embryonic cells, especially where the development of new disease modifying treatments continues to remain difficult for chronic ailments that are still poorly understood.

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— Last Edited by Health_Freedoms at 2015-12-16 19:05:02 —

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