Stem Cell Trials for MS Underway

There are several Phase I clinical trials for stem cell treatments for MS currently underway or recruiting participants but these in themselves are only aimed at ensuring safety of a particular therapy and noting any potential side-effects or necessary alterations in dosage guidelines. If a clinical trial passes Phase I (which usually takes about a year) and goes onto Phase II then the researchers begin to look at how effective the treatment actually is for the condition. Phase II can take anything from one to three years and may find that the treatment requires modification which then results in another Phase I study having to occur in many cases. If the treatment appears to be significantly effective then a Phase III trial will usually commence in order to compare the new therapy with an existing conventional treatment in order to assess clinical significance and, often, cost effectiveness.


It is easy to see why many potential treatments never become widely available as each phase of a trial costs a considerable sum and could take years to construct, carry out, and analyze. The Phase I trials of stem cell treatments for MS may mean that a therapy is available in the next decade or so, but it is likely to take longer for any significant proportion of sufferers to be able to receive these such treatments.

Currently Available Stem Cell Treatments for MS

Many clinics have been carrying out stem cell treatments claiming to treat neurological disease for a number of years but there has, until now, been little to support such action. However, the method of introduction of the stem cells, the culturing of the stem cells and their origin, along with the conditions of transplant (including manipulation of the blood-brain barrier) remain extremely important factors influencing the outcome of stem cell treatment. Many of these careful controls are not yet fully understood, making an infusion of adult stem cells into the peripheral blood at an unregulated overseas clinic highly questionable for any condition, neurological or otherwise.

Overseas Stem Cell Clinics Treating MS

Where clinics are offering stem cell treatments for MS, it is important that patients understand that there have been no such treatments clinically approved at this time and that these clinics often use unsubstantiated hearsay to persuade vulnerable patients into risky treatments. All stem cell clinics should adhere to Good Manufacturing Process regulations and patients should ensure that they are happy with the standards and experience of the clinic should they choose to go ahead with treatment. If donor stem cells are used, patients may be given immunosuppressant drugs which could interfere with their current medications. Patients should, therefore, be open with their current doctor about the therapy in order to avoid any complications; if a clinic claims not to need to see medical records prior to treatment then they are disreputable and should be reported to their local regulatory body for investigation as this will endanger patients’ lives.

Bogus Stem Cell ‘Trials’ for MS

There may be some unscrupulous clinics who advertise their stem cell treatments for Multiple Sclerosis as part of a clinical trial when the ‘trial’ is simply a sham to circumvent certain national or local regulations. Reputable clinical trials should be registered with their country’s regulatory body and will usually be listed at clinicaltrials.gov. If a clinical trial is looking at stem cell treatment for a number of conditions, rather than just MS, then it is unlikely to be genuine. Occasionally one or more similar conditions may be investigated using the same protocol, such as two autoimmune diseases, but this is rare. Patients should also be wary of any trial claiming that there are no risks to the therapy, or that do not give participants information about the type of treatment, the risks and benefits thought likely, the origin of the stem cells, and other pertinent details. Almost all clinical trial participants are required to sign various disclaimers and informed consent forms and the patient should not feel pressured into this at any stage.

Other Warning Signs a Trial is a Sham

If a trial is allowing seemingly anyone to participate then it is also unlikely to be genuine as most are extremely selective about the patients’ stage and severity of disease, other conditions, and things such as age, gender, and previous medical history. Suspicion should also be aroused if there are significant costs to take part in the trial as clinical trials are usually funded by the government, biotechnology companies, various grants, or the university at which they take place. Patients may have to pay expenses in some cases. Taking part in an unregistered ‘trial’ is not advisable as the researchers are not being held to any specific criteria for good practice, safety, or ethics. Discussing available trials with the MS consultant, nurse, or family practitioner may help a patient locate an appropriate clinical trial of stem cell treatments for MS, as can looking at clinicaltrials.gov and searching for stem cell trials.

References

Ivana Nikiæ, Doron Merkler, Catherine Sorbara, Mary Brinkoetter, Mario Kreutzfeldt, Florence M Bareyre, Wolfgang Brück, Derron Bishop, Thomas Misgeld & Martin Kerschensteiner, A reversible form of axon damage in experimental autoimmune encephalomyelitis and multiple sclerosis, Nature Medicine online, 27 March.

Stem Cell Therapies in MS, Australian MS Society, http://www.mssociety.org.au/documents/StemCellBooklet.pdf