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Monday, March 21, 2011 9:58 PM | Sandra Miller Volg link

I've seen a number of advertisements for stem cell therapy, and thought I'd provide CCSVI Locator visitors with the same resources we provide to patients through Angeles Health, so you can arm yourself with information and, most of all, the right questions about the treatment options available to you.



As this story by CBS News' 60 Minutes  (21st Century Snake Oil?) makes clear, there are unethical opportunists in the field of stem cell treatment.  The treatments cost patients a lot - not just in terms of money, but also in hope, so this post will provide some guidelines on how patients can protect themselves and ensure they are getting the treatment they expect.



Regenerative Medicine


Regenerative medicine refers to the repair of organs or tissues damaged by trauma, aging or disease through the replacement of diseased cells with healthy cells, such as stem cell therapy initiates, so that function is improved or restored.  



Because stem cell therapy is not widely available and media discussion tends to focus on the highly divisive issue of embryonic stem cells, many people consider this to be a new and not well understood (and therefore risky, for the patient) area of medical research, but the opposite is true. Consider: more than 50,000 peer reviewed stem cell research studies registered in just the past 5years in the National Institutes of Health library!



In theory, any disease condition resulting in degeneration of tissue can potentially be treated with stem cell therapies, including stroke, heart disease, diabetes, Parkinson's disease, muscular dystrophies, macular  degeneration, spinal cord injury, liver disease and even Multiple Sclerosis - to name just a few.




Assessing Stem Cell Therapy Providers


There are a number of organizations, including nonprofits, that act as oversight bodies for the stem cell industry that provide resources for patients seeking treatment.



The International Society for Stem Cell Research (ISSCR) is a non-profit organization with a mission to promote public education in all areas of stem cell research and application.  The ISSCR provides a helpful  Patient Handbook (translated into Italian, German, French, Japanese, Persian and Spanish.



The International Cellular Medicine Society (ICMS) is a nonprofit dedicated to patient safety and peer oversight regarding the medical use of these promising therapies.  The ICMS accreditation program investigates registered stem cell treatment programs on clinical practices (including cell collection, processing and implantation) , processes, and patient candidacy protocols.



Check out this Patient brochure from the ICMS



A quick summary of some of the key questions both the ICMS and ISSCR recommend:



  • Is the treatment  for this specific disease or condition?

  • Is the treatment part of a formal clinical trial?

  • Is there a registered protocol for this proceure?

  • How are the stem cells identified, isolated and grown?

  • What is the source of the stem cells?

  • Are the cells differentiated into specialized cells before therapy?

  • How are the cells delivered?



What is a protocol?


If you ask,  "is there a registered protocol for this procedure" how can you recognize a good answer? (Hint: "sure!" is not one of them).  This is an important question because a protocol provides many protective measures for the patient.



  • it acts as a control to eliminate the impact of extraneous/specious causal variables

  • stands on the shoulders of existing knowledge, e.g. is based on an identifiable bibliography of peer-reviewed research, which provides the basis for evaluating published results

  • is reviewed and validated by independent bodies e.g. IRBs

  • includes measurements of pre- and post- therapeutic results validated by the scientific community


For example, the protocol for stem cell therapy for congestive heart failure for patients receiving treatment at Hospital Angeles is registered with the ICMS:




Protocol TGI-ME-001: An Open-label, Non-Randomized, Single-Center Registry Study to Assess the Safety and Cardiovascular Effects of Intramyocardial Implantation of Autologous Adipose-Derived Stem
Cells in Congestive Heart Failure Patients


 


Angeles Health International MS treatment program includes CCSVI intervention as well as (adult, autologous) stem cell therapy.  For more information please join one of the informational live medical webcasts here.