New unproven stem cell treatment via IV and mannitol causes concern

We have been made aware that there’s a new kid on the block in terms of unproven treatments, which is a new route of administration of stem cells at the X-Cell stem cell clinic based in Germany.

As a brief background of the story to date, last year, a group of international researchers collectively known as ALSUntangled investigated the claims of X-Cell.

ALSUntangled wrote, and published an article (in the journal ALS) on the X-Cell clinic which concluded that until they demonstrate the safety and effectiveness of their stem cell treatment through a rigorous clinical trial that they would not condone X-Cell centre’s protocol for people living with MND. We wrote about this in our ‘X-Cell Stem Cell Centre has been investigated by ALSUntangled’ blog article.

X-Cell has now adapted their strategy to use intravenous (IV) administration for stem cells, meaning that the cells are delivered into a vein in the arm rather than via surgery on the brain or spine. X-Cell claim that they are able to use this new, far less invasive route of administration because they also give patients IV mannitol to help the stem cells gain access to the central nervous system. Mannitol is a drug used to draw water out of the brain in cases of cerebral oedema (swelling of the brain). There has been research into mannitol use to ‘open’ the blood brain barrier for chemotherapy to improve delivery of drugs to tumors in the brain. However, there is a big difference in trying to get a reasonably small chemical through the blood brain barrier – which in real life terms is like a sieve from the blood through to the brain, and trying to get comparatively huge stem cells through the blood-brain barrier. Unless research is published to demonstrate that this is possible, then it is an unproven method.

We are aware that unproven treatments can seem attractive to people affected by MND given the lack of a treatment. However, they often come at a large cost and have not demonstrated their effectiveness in rigorous clinical trials. To find out more about what makes a good clinical trial, visit our website: ‘what makes a good clinical trial’, or ‘unproven treatments’.

If you are considering an unproven treatment and would like to know the facts about the information they provide, please contact us at research@mndassociation.org. We provide the facts so that people affected by MND can make up their own minds about whether it’s an option they would like to consider.

*Updated – the X-Cell centre has now been closed due to the German Government tightening the loophole that allowed the centre to offer unproven stem cell treatments.

X-cell stem cell centre has been investigated by ALS Untangled

With the internet providing an expanse of ‘quackery’ jumbled up with facts, it’s becoming increasingly difficult for anybody to know what source of information can be trusted. This issue is especially apparent to us when we add unproven treatments into the mix. An unproven treatment is, quite literally, a treatment that has no reliable proof for its benefit as a treatment.

As a bit of background, the only way that a treatment can be moved from being ‘unproven’ to ‘proven’ is by conducting a series of controlled clinical trials that can confirm that it is more effective at treating something than a ‘dummy drug’ – called a placebo. This may seem a bit bureaucratic and time consuming but it is a necessary step in finding a truly beneficial treatment for any disease or ailment. Until a treatment has proven itself to be effective, it remains unproven.

So, to shine some light on the clouded situation of where the facts lie within unproven treatments advertised over the internet, a group of international researchers, collectively known as ALSUntangled (ALSU) was set up. ALSU’s most recent investigation was into a stem cell treatment that is provided by a German clinic called ‘X-Cell Stem Cell Centre’.

The X-cell centre is a clinic based in Germany that injects a person’s own stem cells – extracted from their bone marrow, back into them and claims that it can treat MND (as well as a large number of other conditions). To-date, no such stem cell treatment has undergone any clinical trials that have demonstrated their safety and effectiveness. The use of stem cells as a treatment is therefore regarded as an unproven.

ALSU therefore set out to find out if there was any truth behind the X-Cell Centre by investigating:

  •  The procedure that they adopt is scientifically sound
  • The progression and opinions of three people who went to the X-Cell Centre.

From this, ALSU concluded that the data provided on the X-cell website is flawed and suggest either its removal, or for them to add a disclaimer to alert readers to its flaws. From the small number of people they followed, none showed signs of improvement. ALSU therefore concluded that until they demonstrate the safety and effectiveness through a rigorous clinical trial that they would not condone X-Cell centre’s protocol for people living with MND.

ALSU have published these results in a free to read article in the Journal ‘ALS’, which is written in an accessible way. ALSU also have a twitter page where people can suggest unproven treatments that they should investigate. More information on stem cells as a treatment for MND can be found on the stem cell pages of our website.

ALSU are not alone in their endeavour, as within the research development team a number of us (Brian, Belinda, Kate and I) are able to make sense of the claims of unproven treatments for MND. We provide people with the facts so that people affected by MND can make up their own minds about whether it’s an option they would like to consider.

If you are considering an unproven treatment and would like to know the facts about the information they provide, please contact us at research@mndassociation.org.

*update – The X-Cell centre has now been closed down by the German Government due to a loophole in law being tightened.