Stem Cell Therapy - Ready for Prime Time?

Stem Cell Therapy - Ready for Prime Time?

Stem Cell Therapy - Ready for Prime Time?

Adult stem cells hold enormous potential in the treatment of disease, but more importantly they do not carry the burden of controversy that has surrounded embryonic stem cells for well over two decades

   

Stem Cell Therapy - Ready for Prime Time?

image by: Acn20

When you see the words 'stem cell' you might reasonably expect to read some debate about the ethical appropriateness of using stem cells from discarded fetuses for research. This emotional issue has dominated the dialog regarding stem cell usage for the past decade. However, here's a fascinating component that doesn't receive much press. Stem cells don't just exist in the embryo. There are stem cells in the adult body as well and these 'adult stem cells' are necessary for tissue regeneration throughout life.

Think of skin growing back after an injury, lost blood being replaced and so on. Plus, adult stem cells seem to be more flexible than we originally understood them to be. Up until recently it was thought that adult stem cells could only reproduce the tissue specific to the organ they came from. However, recent studies have shown that adult stem cells can differentiate into different tissue types. For example: Neural stem cells have been induced to create blood and skeletal muscle and bone marrow cells can create muscle and liver cells.

So, actually there is a bright light in the stem cell arena these days, i.e., using adult stem cells not just for research but as a therapy to treat a variety of diseases that up until now, did not have many treatment options. Sounds great …the problem is, much of adult stem cell therapy is not approved for use in the United States, Canada or the UK, so the treatments take place in other countries.

The question becomes, do you risk getting unapproved therapies in an international setting or remain committed to proven therapies. Quite a dilemma! The answer may become more evident by exploring stem cell basics and the advances being made with adult stem cell therapy.

Stem Cell Basics

Stem cells have almost miraculous curative properties. Once a human egg is fertilized, it begins to divide, from one into two cells, two into four and so on. These early cells are not specialized, meaning that they are not predestined to become liver cells or brain cells. These cells can become any kind of cell that the body needs in order to function.  Properly known as embryonic stem cells, these “totipotent” cells can self-renew and create cells that will go on to become specialized cells. It is thought that once a cell becomes specialized, it loses the ability to return to the undifferentiated stage or to self-renew.

It’s this incredible capacity to regenerate and then differentiate that makes embryonic stem cells so very exciting as a possible vehicle to rebuild damaged tissues in the brain (Parkinson’s Disease, Alzheimer’s), the heart and elsewhere. But as you probably already know, for some segments of the population these undifferentiated cells represent human life even at the one cell, undifferentiated stage. They are opposed to propagating additional human cells from embryonic stem cells and using them for disease treatment research.

In spite of the overriding ethical issues the embryonic stem cell debate will continue because:

  • Embryonic stem cells can contribute an endless supply of new cells; adult stem cells cannot.
  • Absent the controversy, embryonic stem cells are easily available in great quantity from fertility clinics. Adult stem cells, on the other hand, are much more limited in supply and more difficult to harvest.
  • Embryonic stem cells provide a pure, controlled line of new cells, an important characteristic for doing research. Adult stem cells are much more differentiated, making controlled experimentation more difficult.

On the other hand adult stem cells, like embryonic stem cells, hold enormous potential in the treatment of disease but do not carry the burden of controversy.

One of the most well-known uses of adult stem cells is the bone marrow transplant, used to treat leukemia and other types of cancer and blood disorders when chemotherapy can’t do the entire job.

The patient’s existing bone marrow along with all the abnormal leukocytes are destroyed with radiation and chemotherapy. Then the patient is injected with healthy bone marrow which includes adult stem cells from a matching donor. In a successful bone marrow transplant, the stem cells will migrate to the bone marrow and produce new, healthy leukocytes. This treatment has been in use for about 40 years.

Plus, adult stem cells do have some advantages over embryonic stem cells:

  • In order for an embryonic stem cell to product a differentiated cell, a suitable environment must be engineered. Adult stem cells are already specialized so inducing growth is not as difficult.
  • Adult stem cells can be harvested then returned to the same individual, reducing the potential for rejection whereas embryonic stem cells could be rejected.

Reports of possible success using adult stem cells to treat disorders are emerging every day.

  • A major study has shown that treating heart muscle that has been damaged by a heart attack with stem cells can repair the injured heart tissue.  Patients who were studied showed a measurable improvement in heart and lung function. 1
  • UCLA researchers reported the first successful adult neural stem cell transplantation to reverse the effects of Parkinson's disease and demonstrate the long term safety and therapeutic effects of this approach in spring 2009. 2
  • Research has shown a variety of promising approaches to the treatment of Alzheimer’s with adult stem cells. Adult stem cell therapy may offer a safe and effective treatment for a disease which was previously considered to be irreversible. 3
  • In a breakthrough trial, 15 young patients with newly diagnosed type 1 diabetes were given drugs to suppress their immune systems followed by transfusions of stem cells drawn from their own blood. The results published in the Journal of the American Medical Association (JAMA) show that insulin-dependent diabetics can be freed from reliance on needles by an injection of their own stem cells. The therapy could signal a revolution in the treatment of the condition. 4
  • Twenty-three patients regained their eyesight following limbal (adult) stem cell transplants. This treatment has helped many suffering from blindness for years, including victims of Iraqi mustard gas attacks. 5
  • Ninety percent of 19 patients with various autoimmune disorders, such as systemic lupus, are in remission or have improved after treatment with their own blood stem cells. 6

This is great…sign me up!

If you are suffering from any of dozens of disorders that may be helped by adult stem cell therapy, you’re probably looking for information about where to find the nearest treatment center. Therein lies the problem. Most of the success with adult stem cells has happened in research studies. There are very few adult stem cell procedures that have either been approved by the FDA or accepted by the medical community.

That’s due to a combination of:

  • Overshadowing by the embryonic stem cell debate;
  • The field is very new and there has not been enough time to do the research;
  • Limited funding, although adult stem cell research has received more funding than embryonic stem cell research and there are now plenty of private companies working on the problem.

At the beginning of 2009, Geron Inc. was the first biotechnology company to get approval from the regulators to commence Phase I studies, which meant it could start injecting living cells, as cell therapy, into the damaged spines of people suffering total paralysis from the chest down.   However, their timeline to market is about ten years.

Osiris Therapeutics’ biologic drug candidate, Prochymal is in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn’s disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the FDA. 7

Unfortunately, most of these very promising therapies that have been showing significant success in clinical trials will not be available commercially for many years …in the United States or Canada or even the UK.

However, many other countries are developing thriving businesses treating people using stem cell therapy. With far fewer regulations to restrict availability in other countries, adult stem cell treatments are available to those who can afford to travel and pay the premium price for treatment. Treatments vary in cost from $15,000 to $80,000 or more. One facility even offered financing through their financial affiliate! In a search for adult stem cell centers on Google, page one of the results offered clinics in:

  • Panama City
  • Cologne, Germany
  • Dominican Republic
  • Bangkok, Thailand
  • Lemana, Switzerland

If you are suffering from a disease or condition that could be treated with better results somewhere else in the world do you take a chance internationally or play it safe and stay.

Here are some suggestions for helping you make a decision about whether or not to pursue adult stem cell therapy in an international setting. 

Pros:

  • There are some amazing results being reported. If international treatment is your best chance for a longer life or better quality of life, it makes sense to do it.
  • Many international facilities are affiliated with or owned primarily by physicians trained in the U.S., who are of the opinion that they can offer more options for their patients by offering stem cell therapy in a clinical setting that meets similar U.S. quality standards but takes place in an international medical facility.
  • Many mistakenly believe that the only quality care is available in the United States/Canada. But, that’s simply not the case. Many countries, both industrialized and emerging, have excellent medical facilities and stellar reputations for quality and innovation.
  • Physician advocates for stem cell therapy say that using stem cells is not very different from ordering a special formulation from a compounding pharmacy or prescribing a drug for an off-label use; it’s the way the practice of medicine evolves over time.
  • Clinical trials are difficult to qualify for and you could be in the control group, which can mean that you don’t receive the real treatment.  However, if you are in a no-treat control group, you are often offered the opportunity for treatment after the study is completed.

Cons:

  • Success is never guaranteed. People need to remember that when an international clinic touts its success stories, they are just that, stories. There may be three or four failures or disasters for every success. There’s no way to know that because there are usually no rules for how the clinic provides information.
  • Although there are certainly many very fine institutions internationally, it’s hard to know if the stem cell therapy clinic that pops up to cater to medical tourism falls into the “very fine” category or not.
  • You may be paying exorbitant fees for procedures that have no record of performance, or at least no record that has been reviewed by physicians who are capable of making determinations about treatment value.
  • You may be paying for less value than you are expect, depending on the clinic’s methods of obtaining/managing cells and their method of introducing cells into the body.  
  • Unlike Canada, the UK or the U.S.,  there are usually no ongoing clinical trials.
  • International stem cell therapy can be enormously expensive. If your situation is dire or you have access to funds, the cost may be a lesser concern to you. However,  if you are managing with conventional treatments, it may make much more sense to save your time and money.

Once you have made the decision to seek international treatment you can increase your chances of success by following these simple guidelines.

Investigate worldwide clinical trials

Even if you don’t think you are eligible, find out what trials are going on and what they are indicating about effectiveness of treatment. For example, if the treatment you are considering has so far proven only to be valuable for children, you may want to weigh that information into your thinking. Second, if there’s no research related to the stem cell therapy you are considering, you need to think about whether there’s value in that treatment.  The Adult Stem Cell Research Network and the Cell Therapy Foundation, both excellent resources for adult stem cell therapy, should be a part of your due diligence.

Facility Specialization

Always try to pick a facility that specializes in your disorder. That way you have more assurance that they have experience and can be assured that they are not selling a snake oil type remedy. It’s not outside the realm of possibility that a clinic will advertise its therapy as “good for everything” not unlike medical potions of the 19th century that cured everything from premenstrual problems to gout to liver complaints.

The International Cellular Medicine Society has compiled a report that details 22 of more than 200 clinics around the world that offer such therapies for ailments such as diabetes and Parkinson's disease. The survey, which weighs the costs and complexity of the therapies offered, provides patients and clinicians with the information it gathered so they can make informed decisions, making no direct judgments about the clinics. 8

Credentials/reputation

Investigate the credentials of the facility and the providers. If there are U.S. MDs involved, you can check with the state medical board for whatever state your MD is licensed in. For non-U.S. physicians, contact the local department of health in that country as a start. They will be able to tell you how to find information on the doctor’s education and credentials and the facility’s certifications. Ask how many procedures have been performed for people with your complaint. Avoid being a guinea pig.

The ICMS has also established a treatment registry, where the health of patients treated at registered clinics can be tracked for up to two decades. Meanwhile, the International Society for Stem Cell Research (ISSCR) launched a task force last year to identify stem cell therapies unsupported by published scientific evidence.  9

Stem cell Preparation and Administration

Most patients have no idea that the preparation and administration of the stem cells can have such a significant impact on success. You should be sure you understand how your clinic operates and whether or not their methods make sense for the particular therapy you are seeking.

There are three methods for obtaining and preparing stem cells.

  1. Stem cells are collected from the body (from bone marrow, for example, then centrifuged to concentrate the cells. This method produces a mixture of cells, both stem and non-stem.
  2. Stem cells are isolated from the specimen and treated with growth factors to stimulate their activity.
  3. Stem cells are both cultured in the lab to expand yield and treated with growth factors as in #2. This method is the gold standard for stem cell therapy. If your facility is using methods one or two, you will receive less benefit

And there are three methods of stem cell administration.

  1. By intravenous line or injection under the skin. These methods are simple and inexpensive but least effective. IV administration causes many cells to be lost in the lungs. Under skin injection does not have therapeutic value for distant sites such as heart and lungs.
  2. By direct injection to the organ or site. This is another relatively inexpensive technique and results in cells being in closer proximity to the area of need, but it is still imprecise.
  3. Injection under imaging. This is the most challenging technique but has the best results. The injection of cells is guided by imaging, so the physician can locate the cells precisely where they need to be, to function optimally.

The Bottom Line

It's time to toss aside the embryonic stem cell debate and fund adult stem cell research. Adult stem cell therapy holds the promise of eradicating many of the diseases that continue to plague people.

However, the research to realize that potential is still in its early stages making the treatment largely unavailable in Canada, the U.S. and the UK. If you are considering traveling internationally to seek treatment that is unregulated, be sure that you understand exactly what kind of therapy you are purchasing and who will be providing the service before making the commitment.

Published May 28, 2010, updated September 15, 2012


References

  1. Adult Stem Cell Therapy Shows Promise for Heart Attack Patients, Wake Forest Baptist University, Feb 25, 2010
  2. Ertelt S, Adult Stem Cell Research Reverses Effects of Parkinson's Disease in Human Trial, Lifenews.com, February 16, 2009
  3. Alzheimer's slowed by stem cells from umbilical cord blood, Stem Cell Institute
  4. Diabetics cured in stem cell treatment advance, NHS, 2007
  5. Holland EJ et al, Management of Aniridic Keratopathy With Keratolimbal Allograft: a Limbal Stem Cell Transplantation Technique, Life Issues Institute
  6. Rosen O et al, Autologous Stem-Cell Transplantation in Refractory Autoimmune Diseases After in Vivo Immunoablation and Ex Vivo Depletion of Mononuclear Cells,  Arthritis Research 2, 2000, p. 327 - 336
  7. Hill E, The Stem Cell Therapy Market: Picking the Winners, Cambridge Consultants
  8. Offshore Stem Cell Survey Report, International Cellular Medicine Society, 2010
  9. Guidelines for the Clinical Translation of Stem Cells, The International Society for Stem Cell Research, December 3, 2008

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