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.