Tuesday, January 28, 2020

ARE YOU A STEM CELL TOURIST ?

Stem cell tourism is a term recently coined to describe a growing practice among patients to pay large sums of money to private clinics for often unproven stem cell therapies. Patients can be desperate because conventional medicine has failed to provide a solution for their particular condition. For diseases affecting children, emotions may run particularly high: the children themselves cannot make properly informed decisions, so parents face the additional conflict of wanting the best for them while, at the same time, having to protect them from undue risk. Advertisements for these clinics, often outside the patient’s own country, claim that stem cell treatment can benefit or cure complaints ranging from diabetes, stroke, paralysis caused by spinal cord injury, cerebral palsy, and Lou Gehrig’s disease (ALS), to wrinkles in the skin and age-related hair loss in men.

Potential Risks of Stem Cell Therapies
Uta Kunter, Jürgen Floege, in Regenerative Nephrology, 2011





Stem cell therapies are very likely to have a major impact on regenerative medicine, but for them to succeed we need to be aware of their specific challenges to avoid setbacks as experienced in the first gene therapy trials. In stem cell therapies, just as in gene therapy, malignancies are a major concern. Other concerns relate to contamination of cell preparations and unwanted formation of ectopic tissue (maldifferentiation), but also to the validity of experimental results, e.g. stem cell markers and heterogeneity of stem cell preparations. Consequently, this chapter will address both the medical safety aspects of stem cell therapies and the scientific safety of stem cell-related data. In reflection of the current literature on stem cell therapies in nephrology, the main focus here is on mesenchymal stem cells (MSCs) and other adult bone marrow preparations. However, with rapid developments in the field, safety aspects concerning stem cells other than MSCs may gain importance in the near future and therefore will be mentioned throughout this chapter.

Although there is some progress using stem cells (MSC) in animals, human clinical research has many ethical issues. Questions have arisen about the safety of stem cell transplantation.  There are those who are against 'letting the genie out of the bottle". Concerns regarding maldifferentiation, cancer, and ectopic tumor development have been raised. The Federal government banned the use of Federal money to fund research with HESCs (Human embryonic stem cells)
Ethical concerns included the definition of human life and the pluripotent nature of embryonic stem cells.

There are no FDA guidelines regarding stem cell usage. Neither have there been any documented regulations as to the preparation, indications, side effects, dosing, adverse reactions.  The typical label which accompanies all FDA approved medications provide that type of information for medications you purchase at your pharmacy.

Currently, the only stem cell therapies approved by the FDA use cells from bone marrow or cord blood to treat cancers of the blood and bone marrow. But doctors in the Cell Surgical Network have moved ahead with using cells for autoimmune, neurologic, and other serious conditions.

If you are interested in the current network of private and commercial stem cell doctors or clinics refer to the Cell Surgical Network. Health Train Express advises extreme caution in choosing this option.  Many of these stem cell doctors are no longer offering this treatment as a result of a court action with a permanent injunction regarding these sources of stem cell treatments. There is also a monograph by Dr. Elliottt Lander and Dr. Mark Berman on the history of Stem Cell treatments along with several anecdotal stories.

FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) Product List

If readers wish to learn more and read peer-reviewed scientific articles can be found at PubMed or Google Scholar

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