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Stem Cell Clinics – Questions to Ask


Stem cell clinics – things to think about

Exciting progress is being made through innovative and carefully conducted research related to the potential of many types of stem cells for slowing MS disease activity and for repairing damage to the nervous system.

At present, there are no approved stem cell therapies for MS. There are different types of stem cells and the effects of receiving them depend on additional factors, including the specific procedures used to prepare and administer them, and biological conditions in the person to whom they are given.  Stem cell therapy is still in the experimental stage, so it’s important for people to have the best available information to understand this exciting area of research and make decisions related to this complex issue.

In the U.S. and in other places around the world, for-profit stem cell clinics are appearing in increasing numbers. These clinics claim to have treated people with MS and people with many other disorders with stem cells. However, these clinics are unregulated and none have provided medical evidence that their treatments work or are safe.

Ohio State researchers recently reported results of a survey of academic neurologists in the United States regarding their patients who had traveled to clinics in the U.S. and abroad to receive stem cell procedures for MS and other neurological disorders. Of those survey responders who had patients who attended a stem cell clinic, 75% were not aware of a patient who experienced complications; however, 25% reported having patients whose stem cell procedures led to complications including strokes, meningoencephalitis, quadriparesis, MS deterioration, sepsis, hepatitis C, seizures, meningitis from intrathecal cell injections, infections and spinal cord tumors. At least three reported having patients who had died from these procedures.  Read the abstract presented at the ACTRIMS meeting March 1, 2019

An earlier study published in June 2016 confirmed that many different types of unproven stem cell treatments are being offered in these clinics. The study highlighted concerns for the safety of people who undergo these treatments, emphasized the need for better oversight and raised ethical issues and regulatory concerns related to marketing unproven treatments for a range of health conditions.

The paper’s findings support the need for stem cell therapy to be explored in the context of carefully conducted clinical trials that can determine what the optimal cells, delivery methods, safety and actual effectiveness of cell therapies might be for people with MS.
For more details about this study:

Many experts in the MS community have expressed concern that:

  • In many countries these stem cell clinics are not held to strict sanitary guidelines and are allowed to operate without oversight over the safety of their procedures.
  • The sources of the stem cells they use are not always made clear, or the procedures they use to derive them or ensure they are free from infectious agents.
  • Safety of the procedure itself, and its long-term consequences, is a major issue. Areas of concern include the question of whether the cells could cause the severe immune attack known as graft-versus-host disease, or grow uncontrollably once inside the body and cause tumors or other serious problems. Another concern relates to whether follow-up care would be available if complications or other issues arise after a person gets home.
  • There is often no plan for how the safety, side effects and effectiveness of this experimental procedure will be measured and monitored over time.
Read the FDA's advice to consumers about stem cells

Important questions to ask when considering treatment at a stem cell clinic

Anyone who is thinking about stem cell therapy should consider these concerns and evaluate carefully the potential adverse events that will be outlined in the consent form usually provided before medical procedures are performed, and the clinic’s procedures for managing any complications which may arise during or following the procedure.

  • What type of cells will be used for the procedure, and why?
  • Does the clinic offer stem cell treatments for many different conditions? If the answer is yes, this is a warning sign. Because stem cells that are specific to certain tissues cannot make cells found in other tissues without careful manipulation in the lab, it is very unlikely that the same stem cell treatment will work for diseases affecting different tissues and organs within the body. Be wary of claims that stem cells will somehow just know where to go and what to do to treat a specific condition.
  • What are the promised benefits of the procedure?
  • Can the staff provide studies published in peer-reviewed medical journals that show evidence that the same cells and techniques have proven benefit?
  • What type of safety certifications does the clinic have? (In the U.S., the FDA has to approve the use of stem cells, even if they are taken from your own body if they are manipulated or used for any purpose other than their natural function. The cell production facility also should have accreditation from FACT -- the Foundation for the Accreditation of Cellular Therapy.)
  • What is the source of the cells to be used for the procedure? (Cells other than those from a person’s own body may cause a severe immune attack known as graft-versus-host disease.)
  • How were the cells obtained?
  • What procedures are used to ensure the cells are free from contaminants and infectious agents?
  • By what means will the cells be delivered into your body?
  • What procedures are followed to ensure sanitary conditions?
  • Will the procedure hurt or likely to cause other side effects?
  • What are the potential risks of the procedure? (These should be outlined in the consent form you will be asked to sign.)
  • How are potential risks monitored, and for how long? What procedures are used to follow the subsequent course of people who receive these treatments, and who reviews this information to detect potential problems?
  • How will potential benefits be measured and over what time period, using what follow-up procedures?
  • What are symptoms you should be looking for that may signal an adverse reaction to the procedure?
  • How will potential complications be addressed?
  • Will potential complications be covered by your health insurance?
  • How much will you be expected to pay for the procedure and all other associated fees and travel? 

If you don’t get satisfactory and specific answers to these questions, discuss your decision with your healthcare provider and proceed with extreme caution.
Red flags that should raise concern include:

  • There is no research published in peer-reviewed journals using these cells and techniques to back up claims of benefit. Instead the clinic promotes testimonials from patients who have undergone the procedure;
  • Cells are from an unknown source, or your own cells are being used for a purpose that is not part  of their normal function;
  • The clinic cannot show proof of certification;
  • The treatment is claimed to be a cure;
  • The clinic offer stem cell treatments for many different conditions
  • You are not asked to read and sign a consent form outlining potential risks;
  • The clinic has no procedures for addressing complications which arise after you leave, or for following the subsequent course of people who receive the therapy. 

Read more about 
Stem Cells and MS
Read blogs about stem cells and MS
Read more about stem cells from the International Society for Stem Cell Research


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