Feb 06, 2009
Update: Cell Therapy for MS and Stem Cell Clinics
The National MS Society has determined that research involving all types of stem cells holds great promise, potential, and hope for people affected by MS, and that this will improve our understanding of the MS disease process and lead to new pathways for therapeutic intervention.
There are many types of stem cells, and varying degrees of research and knowledge about different types of stem cells and their potential usefulness for treating MS. At present, there has been no proven therapy for MS that uses stem cells.
Among the types of stem cells being investigated in people at present are umbilical cord cells, placental cells, and mesenchymal (blood- or bone marrow-derived) cells. To date, human embryonic stem cells have not yet been used to treat MS in any legitimate clinical trials.
Stem Cells to “Reboot” the Immune System
There is a procedure being investigated in MS that is variously called “hematopoietic stem cell therapy,” “bone marrow transplantation,” and “autologous stem cell transplantation.” In treating MS, the procedure generally involves removing a person’s cells from the bloodstream that are capable of regenerating into new immune cells. These “stem cells” are stored, and the rest of his or her immune cells are destroyed by chemotherapy or radiation or both. Then the stored stem cells are reintroduced by injection. Eventually they grow and repopulate the body with immune cells. This procedure has also been done using a matched donor’s cells (allogeneic cells), for the most part to treat cancer in some people who also have MS. The hope is that the new immune cells will no longer attack myelin or other brain tissue, so that the person has perhaps a completely new immune system.
This procedure is strictly investigational – it was developed in people who have very serious cancer, and it carries the risk of death because the body is nearly helpless against infection during the several weeks it takes for the immune system to be restored. There is no proof yet that it can “cure” a person with MS, but research is ongoing in several centers in the United States, Canada and abroad to determine whether it can halt progression or bring on remission of disease.
Stem Cells to Repair MS Damage
The other line of stem cell research in MS relates to efforts to repair nervous system damage. This research is in its infancy, and there is no evidence yet that any types of stem cells can reverse MS damage or restore function. There are a few known research studies being conducted by researchers who are attempting in a controlled fashion to safely test the ability of mesenchymal stem cells to treat MS damage.
Some research in MS animal models also suggests that the administration of brain stem cells may reduce inflammation, rather than actually regrowing brain tissue. This work is ongoing by investigators around the world.
There have been a number of stem cell therapy clinics around the world that have claimed to have successfully treated people with MS and people with many other disorders with stem cells. However, none have provided scientific or medical evidence that their treatments work, either short-term or long-term, or are safe. Some of these clinics have been closed down when health authorities learn of their practices, but they continue to crop up especially in countries with weak oversight by health authorities.
Concerns about these clinics include:
SAFETY:
-Offshore 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. A pooled source of cells – for example, from many donors’ umbilical cords – might be used and this leads to many concerns over safety and infections.
-What is the route of delivery? What is the assurance that intrathecal (into the spinal fluid) delivery or intracranial (into the brain) delivery of cells is safe? (Even in the most hygienic conditions, these procedures have significant risks.)
-Safety of the procedure itself, and its long-term consequences, is a major issue. Will the cells cause the severe immune attack known as graft-versus-host disease? Will the cells grow uncontrollably once inside the body and cause tumors or other serious medical problems?
-What if complications arise after a person gets home from a procedure done out of the country? It may be hard to get back to the clinic where the procedure was performed to have the complication addressed; it may also be difficult for a physician in the United States to address complications from such a procedure.
- How will safety and effectiveness be measured and monitored – both near and long-term? Since this is an experimental procedure, is there any evidence that the clinic is tracking improvements and declines in their patients after they return home? Without careful, long-term monitoring of patients, how can it be determined that patients have no side effects?
UNSUBSTANTIATED CLAIMS:
-The claims made by many stem cell clinics go well beyond what is likely for an untested therapy and should be regarded with extreme skepticism.
-Little has been published in scientific journals for other doctors to scrutinize.
-MS is an especially unpredictable disease, and medical history shows that controlled clinical trials are necessary to determine whether a therapy actually provides benefit. One reason is that a person with MS may experience spontaneous remissions or improvements without therapy. Another is that people with MS have been found to be particularly susceptible to the placebo effect, and tend to feel better at least temporarily at the beginning of a new treatment. This effect may be compounded by traveling far for an expensive treatment in a spa-like setting. Clinical trials that control for the biases introduced by the expectations of the patients as well as their doctors are necessary to determine whether therapies are effective and safe.
-To date, there have been no rigorous, controlled clinical studies conducted to demonstrate the ability of stem cell therapies to repair the damage to myelin and other brain tissue in MS.
A reminder: testimonials from patients do not constitute evidence. Stem cell therapy clinics are no different than others who make unsubstantiated claims for therapy. Here is advice from the Society’s brochure (PDF), “Clear Thinking About Alternative Therapies”
Suspect fraud if:
• Promoters suggest an alternative treatment is a “cure” for MS. The grander the claim, the more alarming this signal is.
• You must pay in advance.
• The treatment is available from only one source or works by a “secret” formula.
• A practitioner does not want to work with your medical doctor.
• The promoters claim there is a medical or scientific conspiracy against them.
• Advertising uses testimonials from “satisfied customers.”
• The product or treatment is promoted by:
> telephone solicitation, direct mail, or the Internet
> a TV infomercial that uses a talk-show format
> newspaper ads designed to look like news articles
> a salesperson working for a multilevel marketing organization (known as “pyramid marketing”)
Conclusion
We believe that research in all types of stem cells holds great promise, potential, and hope for people affected by MS. Researchers around the world are investigating many types of stem cells and potential ways they may be harnessed to benefit people with MS. There are many safety and efficacy issues that researchers are working to resolve through carefully controlled research. It has not yet been adequately determined, through rigorous clinical testing, that stem cell therapy is safe and beneficial to people with multiple sclerosis.
Therefore, any participation in new cell therapies outside of rigorously designed, controlled and monitored trials is strongly discouraged. If you or a person you know is not sure whether a therapy being offered is legitimate, consult your neurologist or the National MS Society (1-800-Fight MS).
The National MS Society monitors research reports on all therapies including stem cell therapy, and updates information on this topic on its Website as it becomes available.
Read more information about current research and treatments for MS.