Unproven cell-based treatments for ALS/MND: Lessons from Beijing
02 December 2007
During a presentation at the 18th International Symposium Dutch neurologist, Dr van den Berg outlined the results from his clinical assessment of 12 patients who travelled to Beijing for stem cell therapy.
Dr van de Berg began his presentation by explaining that stem cells injected into SOD1 mouse models have extended the life span of the mice but did not prevent death. The effects of the injected stem cells was similar to the treatment Riluzole.
Dr Huang, of the Institute of Neuro-Regeneration Repair and Functional Recovery in Beijing, has treated over 300 ALS/MND patients with experimental stem cell therapy. The cells used are obtained from four – five month old foetus’ from miscarriages. To have them injected into the brain costs in the region of £13,000.
Dr Huang’s clinic claims to prevent further deterioration in the patient. Patients stay at the clinic from four – six weeks. An inspection of the facilities showed them to be clean, professional and the patients looked to be well treated. However, there was no ethics committee, and, importantly, no proof that the cells survive during the process.
Dr van de Berg outlined the shortcomings of both papers Dr Huang recently had published in a Chinese journal. They were not peer reviewed, the studies were not placebo controlled and the follow up was too short to know if the treatment was truly effective. He commented that it was unethical to ask patients to pay for experimental treatment.
Assessing the patients travelling to Bejing before and after treatment Dr van den Berg found that:
- A few hours after the treatment seven patients believed they had an increase in muscle strength. Three patients felt no change and two felt they had deteriorated.
- The function rating showed improvement immediately after treatment but then quickly deteriorated.
- Forced vital capacity also improved but deteriorated again over time.
- One patient developed deep-vein thrombosis and one experienced respiratory insufficiency due to pneumonia. 10 of the patients have since died, having survived an average or 2.9 years following treatment.
Dr van de Berg findings showed that there was no evidence of long-term (more than four weeks) improvement in people with MND.
Another aspect of this type of treatment is the issue of financial burden. Many patients are able to afford the treatment following fundraising activity. This would also have an impact. As Dr van de Berg says: “It’s difficult to come back and say the treatment had no effect if so many people helped you get there.”
Patients talk to each other during the month long stay and build up relationships. This may also contribute to the short-term effect.
Dr van de Berg concluded by saying: “In my opinion neurologists should discourage their patients from this type of treatment. We need to explain to patients the reason why they feel the immediate positive effect, we should explain how it would be impossible to feel a biological change so quickly.”
Vic Washby who travelled to Beijing in 2005 said: “I didn’t notice any immediate effects but my family and friends said they could see a difference in my voice and my breathing. As time went on I noticed that I didn’t deteriorate as much over the next 18 months. After that I started to deteriorate again. Even if it was the placebo effect it worked for me.”
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Notes to editors
The 18th International Symposium on ALS/MND is taking place in Toronto, Canada, between Saturday 1 and Monday 3 December. The event is organised by the UK-based Motor Neurone Disease (MND) Association and hosted this year by the ALS Society of Canada.
The MND Association says:
There is currently no cure for Motor Neurone Disease, which is why the MND Association is committed to funding and promoting scientific research into possible causes and treatments.
Only a drug called riluzole – brand name Rilutek – has been proved through clinical trials to be a successful treatment for people with MND. It extends life by up to three months.
Even so, there are many other treatments marketed throughout the world for people with MND. However, their effectiveness has not been proved through clinical trials, and the science behind them is sometimes not well understood. The Association does not endorse these treatments.
In addition, we believe that allowing treatments to be made available which have not been through the established clinical trials process encourages unscrupulous individuals to market ineffective treatments for monetary gain.
We would encourage anyone with MND who is considering embarking on an unproven treatment to discuss all the implications with their neurologist before making a decision.
The MND Association says:
There is currently no cure for Motor Neurone Disease, which is why the MND Association is committed to funding and promoting scientific research into possible causes and treatments.
Only a drug called riluzole – brand name Rilutek – has been proved through clinical trials to be a successful treatment for people with MND. It extends life by up to three months.
Even so, there are many other treatments marketed throughout the world for people with MND. However, their effectiveness has not been proved through clinical trials, and the science behind them is sometimes not well understood. The Association does not endorse these treatments.
In addition, we believe that allowing treatments to be made available which have not been through the established clinical trials process encourages unscrupulous individuals to market ineffective treatments for monetary gain.
We would encourage anyone with MND who is considering embarking on an unproven treatment to discuss all the implications with their neurologist before making a decision.
- Session 6B - Evaluating unproven treatments (89kb - PDF)
