Stem Cell Transplantation
Availability: Afghanistan, Dominican Republic, China, Ukraine, and other countries.
Stem cells are the body’s way of repairing itself naturally. They seek out damaged areas and replace the dead cells by transforming themselves into whatever type of cell is needed. Where there is brain damage, they change into brain cells; when you cut yourself, they become skin cells. They then multiply by dividing into exact copies of themselves (mitosis). The problem is, the body cannot always produce enough stem cells to repair itself. When this happens, stem cell research has shown that a stem cell transplant can help to repair the body after the onset of illness or injury.1 Stem cell transplantation adds extra stem cells to help regenerate areas of the body that have been badly damaged:
‘To their advantage, stem cells have the capacity to respond actively to their environment, migrate to areas of injury, and secrete neuroprotective compounds, in addition to their potential for generating a variety of new functional cell types.’2
The treatment works by taking cells from a rich source, such as bone marrow or umbilical cord blood, treating them, and then delivering the stem cells to the damaged area. For example, after a stroke, stem cells might be injected directly into the brain, or into the spinal canal via a lumbar puncture. The cells can also be delivered directly to an organ, such as the heart or liver, through a catheter.
- Possible benefits of Stem Cell Transplantation for stroke
There in an increasing amount of research showing that stem cell transplantation can help stroke survivors. For example, scientists at the Stanford Stroke Center injected stem cells into the brains of rats who had suffered a stroke. Their tests showed that the stem cells did move to the damaged areas when they were injected close to the injury. They also found that the stem cells turned into the correct type of cell to make repairs and restore function.3 Another advance, outlined in a press release, offers more evidence that stem cells can repair brain damage after a stroke. A team of researchers at King’s College London developed a tiny scaffolding that supports stem cells. They injected it into the brains of rats and found that ‘it is possible to fill a hole left by stroke damage with brand new brain tissue within 7 days.’4
In 2010, Professor Keith Muir and his research team began a clinical trial called the Pilot Investigation of Stem Cells in Stroke (PISCES). This is the world’s first clinical trial to inject stem cells directly into the brains of ischemic stroke survivors.
Phase I of the trial is complete. This phase was aimed at testing the safety and tolerability of a stem cell therapy called ReN00, which comes from foetal brain cells. The trial consisted of treating a small number of patients with gradually ascending doses of the stem cell therapy over a two year period.
In May 2013 updated interim results from the first 9 patients were presented to the 22nd European Stroke Conference in London. Professor Muir reported that data from these patients has shown no “cell-related or immunological adverse effects”. In this sense, the trial was a success as “the data to date identify no safety issues with the ReN001 treatment – which is the primary focus of this Phase I trial.”
Muir added that most patients also experienced slight improvements in neurological impairment and their ability to undertake day to day tasks. Although, evidence of this kind of functional improvement requires further investigation in a suitably designed Phase II efficacy study. Phase II started in 2014.5
The PISCES trial is being carried out in conjunction with ReNeuron Group plc. The chief scientific officer at ReNeuron, the company that developed the cells, explains that animal trials have already shown a good deal of success using similar methods:
‘We see re-growth of blood vessels, the generation of new neurons, a reduction in scarring and inflammation in the brain …There are a range of things that happen that are best described as the brain to some extent healing itself.’6
For example, Frank Marsh is an 80 year old man who suffered a stroke 5 before; this left him with poor strength and coordination in his left hand and leg. However, since he has taken part in the PISCES trial he has seen improvements in his ability to use his left hand, his balance and his ability to walk unaided.
Mr Marsh said: “I can grip certain things that I never gripped before, like the hand rail at the baths, with my left hand as well as my right. It still feels fairly weak and it’s still a wee bit difficult to co-ordinate but it’s much better than it was.”
Mr Marsh said he hoped the improvements would continue, adding: “I’d like to get back to my piano. I’d like to walk a bit steadier and further.” His wife Claire said: “He had reached a plateau and wasn’t really improving [after his stroke]. But following the operation he is able to do things he couldn’t do before, such as make coffee, dressing, and holding on to things.”7
In 2009, Roland “Bud” Henrich became the first stroke patient to be injected intravenously with his own stem cells as part of a research trial. Doctors farmed the stem cells from his bone marrow. Henrich had suffered a stroke several months prior to the treatment. He had lost his ability to speak and suffered from significant weakness on his right side. Since the treatment, Henrich is able to walk and climb the stairs unaided and his speech is starting to return.8
- Arguments against Stem Cell Transplantation for stroke
Changes in legislation have led to human clinical trials in the UK and USA since 2009.9 Despite this, stem cell transplantation is not accepted by large sections of the medical community. Many doctors believe it is a potential treatment for stroke but is not yet ready to use. They argue that people who are desperate for a ‘cure’ are prepared to try anything. Stem cell treatment has been compared to ‘snake oil’, a tonic that makes great claims but is not backed up by sound medical evidence. Their suspicion is fuelled by the fact that many of the clinics are ‘offshore’. For example, one clinic that treats patients from the USA is in the Dominican Republic.
Another argument against stem cell transplantation is based on the use of human embryo or foetal stem cells. Some clinics do use these stem cells, but not all. It is no longer necessary to harvest stem cells from a foetus. Stem cell treatment clinics increasingly use ‘adult stem cells’, which come from your own body. It is also possible to use cells from umbilical cord blood and possibly even from animals. Recent research has also been conducted into taking cells from teeth. The main benefit of stem cells from teeth is that they can be easily extracted and do not pose rejection issues for patients.10
The high cost of stem cell treatment at private clinics has also raised suspicion. On average, the cost of one treatment falls between €7,500 and €35,000. Add to this the cost of travelling to places such as Ukraine or China, where you might also have to pay for accommodation because most of the clinics are not residential.
Some researchers who support stem cell therapy believe that it will not help every stroke survivor. For example, it might be more difficult to treat brain infarcts involving white matter, which contains myelinated nerve fibres.11
Stem cell treatment is an issue that is legally complex, religiously and politically controversial. As a consequence, there can be sudden changes in regulatory policies.12 This can lead to discontinuation of treatments offered in some clinics or countries, which could result in cancelled appointments. For example, the German authorities passed legislation that resulted in the closure of the controversial X-Cell Centre at the Institute for Regenerative Medicine, the largest stem cell clinic in Europe.13
- Case histories
- This article outlines an element of the stem cell debate and the experiences of Chuck Melton, a burly 24-year-old factory worker who went to China for stem cell therapy.
- This BBC news article tells the story of three-year-old Dakota Clarke. She was born with a rare condition that affected her vision and balance. Stem cell treatment has helped her to “see things that she could not see before”. BBC News Saturday, 16 May 2009 00:29UK.
- Notes and references
- ‘The leading edge of stem cell therapeutics’ by Singec I, Jandial R, Crain A, Nikkhah G and Snyder EY. InAnnu. Rev. Med. 58: 313-328, 2007
- ‘Stem cells for ischemic brain injury: a critical review’ by Burns TC, Verfaillie CM, Low WC. In J Comp Neurol. 2009 Jul 1;515(1):125-44. Review.
- ‘Long-term monitoring of transplanted human neural stem cells in developmental and pathological contexts with MRI’ by Raphael Guzman, Nobuko Uchida, Tonya M. Bliss, Dongping He, Karen K. Christopherson, et al. Edited by Irving L. Weissman, Stanford University School of Medicine, Stanford, CA, and approved April 24, 2007 (received for review October 6, 2006)
- ‘Stem cells could help treat strokes’, BBSRC Press Release, Institute of Psychiatry, News, March 2009
- ‘Encouraging data from stem cell trial in stroke patients as plans for Phase II progress’, University of Glasgow Press Release, May 2013.
- ‘Stem cells injected into the brain of a stroke patient in world first’ by Ian Sample. guardian.co.uk, Tuesday 16 November 2010 13.03 GMT. The Principal Investigator for the PISCES (Pilot Investigation of Stem Cells in Stroke) trial is Professor Keith Muir, SINAPSE Chair of Clinical Imaging, University of Glasgow. It is a joint study between University of Glasgow and the ReNeuron Group, which on its webpage describe itself as a ‘clinical-stage stem cell business’. See: ReNeuron
- ‘Stem Cell trial gives fresh hope to stroke victims’ http://www.heraldscotland.com/news/health/stem-cell-trial-gives-fresh-hope-to-stroke-patients.
- ‘Stem Cells Tested for Treatment of Stroke’ by Deborah Mann Lake. In Texas Medical Center: Issue Date: July 1, 2009.
- A human clinical trial to investigate the benefits of stem cells for stroke survivors was approved in Scotland in January 2009: ‘Restorative therapy in stroke using stem cells’ by Padma Srivastava MV. In Neurol India2009 57:381-6. Nov. 2009. In early 2010, the Gene Therapy Advisory Committee in the UK gave ReNeuron permission to launch a human trial on the effects of stem cell therapy after a stroke. In May 2009, President Barack Obama decided to allow human stem cell research in the USA. This began with a clinical trial on the effects of stem cell therapy on spinal cord injury: ‘A New Stem Cell Era’ by Claudia Kalb.Newsweek, 9 March 2009.
- ‘Stem cell research gives hope to stroke patients’. Psy-Org.com, December 8th, 2009
- ‘Study on stem cells for stroke patients to start in Scotland later in 2009’ by Bryan Christie. In BMJ2009;338:b245.
- Elstner A, Damaschun A, Kurtz A, Stacey G, Aran B, Veiga A, Borstlap J “The changing landscape of European and international regulation on embryonic stem cell research” Stem Cell Research, 2009(2), 101–107.
- Since December 2008 Regulation 1394/2007/EC has been in effect in the European Union. National or community legislation on stem cell research must conform to this legislation by December 2012. For a summary of 1394/2007/EC in the context of German medical legislation please klick here.
Aviva Cohen is the author and CEO of Neuro Hero