De Leon: Medical Tourism and the Future of Stem Cell Therapy (Part 3)

THE International Society for Stem Cell Research (ISSCR), an independent, non-profit organization has been established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application. Members are admitted on the basis of their professional credentials as scientists or clinicians working in the field of stem cell research. Over the years, ISSCR has raised its concerns regarding stem cell therapies that are being offered worldwide before being scientifically and clinically proven safe and effective. The Catholic Church, supports stem cell research, with an introduction for a book on the subject by no less than now Pope Emeritus Benedict XVI.

Associated press has reported that Benedict XVI wrote the introduction for "The Healing Cell: How the Greatest Revolution in Medical History Is Changing Your Life" co-authored by Dr. Robin Smith, Msgr. Tomasz Trafny, and Max Gomez. The Catholic Church supports using adult stem cells in scientific research, especially when it will benefit society. However, The Church has consistently opposed research on embryonic stem cells.

Stem cell therapies are just about all new and experimental. ISSCR contends that most medical discoveries are based on years of research performed at universities and companies, requiring a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people. The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely limited. The best defined and most extensively used is blood stem cell transplantation to treat diseases and conditions of the blood and immune system, or to restore the blood system after treatments for specific cancers. Some bone, skin and corneal diseases or injuries can be treated with grafting of tissue that depends upon stem cells from these organs. These therapies are also generally accepted as safe and effective by the medical community. The ISSCR is cautioning the public to be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated. Snake oil salesmen associated with those clinics are preying on the hopes of desperate patients/potential victims trying to make people believe that such treatment are effective in curing diseases in the absence of strong scientific evidence. If your doctor does not have a compelling reason to believe that your disease can be treated effectively with a therapy that is being offered and is not supported by a compelling evidence in scientific literature and that it hasnt been the basis of sound clinical trials is not open to the light of day and replicated in independent clinics -- then there is reason to be skeptical of these potential therapies and that you should be very cautious in engaging these clinics.

There has been enormous amount of excitement that stem cell treatments offer. It is important to realize that those opportunities are in the future. There are no established and proven stem cell treatments that work yet for some of the incurable diseases today (e.g. spinal injury, or Alzheimers); what works today that we can be sure about is bone transplantation. Therapies based on stem cells are still new and there is a so much that has yet to be discovered and tapped. Furthermore, side effects and long-term safety must be determined, since transplanted cells may remain for many years in patients bodies. Therefore, careful monitoring and extended follow-up of patients who receive stem cell treatments is extremely important. Patients intending to undergo stem cell treatment need to be sure that there is good scientific evidence that the treatment is safe and effective, and that your rights as a patient are being respected. Ask for evidential support pertaining to pre-clinical studies that have been published and reviewed by other experts in the field, and is approved by the Bureau of Food and Drugs administration. Other warning signs offered by ISSCR (www.isscr.org) that each patient should be cautious about include:

1. Claims based on patient testimonials. Patients want to believe so much that a treatment is helping them that they can convince themselves that it has. (Placebo effect) They may even have experienced some recovery unrelated to the treatment. Unless there has been carefully evaluated clinical research it is very difficult to know what is a true effect of the treatment and what you can expect.

2. Multiple diseases treated with the same cells. Unless the diseases are related, such as all being diseases of the blood, different diseases, such as Parkinsons disease and heart disease, would be expected to have very different treatments. Also, you want to be treated by a doctor that is a specialist in your disease.

3. The source of the cells or how the treatment will be done is not clearly documented.

This should be clearly explained to you in a treatment consent form. In addition, there should be a protocol that outlines the treatment in detail to the medical practitioner. The protocol is the operating manual for the procedure. While it may not be made available to you automatically, you should be able to request this. For a clinical trial or experimental treatment, protocols should have been reviewed for scientific merit by independent experts and approved by an ethics committee to ensure that the rights and well-being of the participants will be respected. Ask who has approved this protocol and when the approval expires.

4. Claims there is no risk. There is always risk involved with treatment. Information about the possible risks should be available from preclinical or earlier clinical research.

5. High cost of treatment or hidden costs. It is not customary for someone to pay to be in a clinical trial (other than perhaps travel and other personal expenses). Consider whether you should pay for a treatment that is unproven. Furthermore, ask about the costs of emergency medical care if something goes wrong, particularly if you are outside your own country.

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De Leon: Medical Tourism and the Future of Stem Cell Therapy (Part 3)

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