In a public service TV advertisement recorded about a week before his death, Christopher Reeve urged Californians to support a controversial embryonic stem cell research referendum at the end of 2004. “Stem cells are the future of medicine,” said Reeves in the advertisement.
Ari Seirlis, National Director of the QuadPara Association of South Africa (QASA), regards stem cell treatment with caution, but says, “I read with interest the success stories. However, I hear of far more failures. This does not change my belief that stem cells will play a role in SCI health in the future.”
Stem cells are a basic biological repair kit with the capacity to become any of 200 specialised cells in the body, with the potential to repair or replace damaged tissues. They are found in human embryos, foetuses, children and adults at all stages of development.
Stem cells first became available for research in 1998 when a group led by Dr James Thomson at the University of Wisconsin developed a technique to isolate and grow the cells. Stem-cell research in South Africa has been in limbo for years while researchers waited for draft regulations. The Department of Health finally published these in the Government Gazette of 5 January 2007.
Donrich Jordaan, Sylvean Biotech's director for legal affairs and part-time head of the research unit for policy studies at the University of Pretoria, says, “Provided that certain important ethical guidelines are met, I hope that stem cell research will soon take off in South Africa. Our country has great expertise in the field, and we owe it to future generations to seriously explore the opportunities offered by stem-cell research.”
There are three classes of stem cells: totipotent, multipotent and pluripotent. A fertilised egg is considered totipotent, that is, its potential is total and it gives rise to all the different types of cells in the body. Multipotent stem cells give rise to a small number of different cell types, and pluripotent stem cells give rise to any type of cell in the body, except those needed to develop a foetus.
Greatest therapeutic potential
Pluripotent stem cells have the greatest therapeutic potential, but scientists have to learn how to control their development into other types of cells, and prevent them from being rejected by the patient's immune system. A greater problem is the ethical conflict of using stem cells from human embryos or foetal tissue. The use of adult stem cells overcomes this.
Adult stem cells such as blood-forming haematopoietic stem cells have been used for over 40 years in bone marrow transplants to treat leukaemia, lymphoma, inherited blood disorders, diabetes and advanced kidney cancer. However, these newer uses have involved studies with very few patients. Nevertheless, adult stem cells, as opposed to embryonic stem cells, have been treating patients suffering from over 70 diseases.
There are currently over 1 100 Federal Drug Administration (FDA) approved clinical trials going on in the US using adult stem cells. According to the Family Research Council, adult stem cells have been used successfully in the treatment of spinal cord injuries.
In 2003, Paraplegia News in the US reported on the work of Dr Carlo Lima, a neuropathologist in Portugal. He helps SCI patients regain sensation and feeling by transferring their nasal tissue, containing adult stem cells, to the site of the spinal cord injury.
From 2001 to 2003, Lima operated on four female and three male patients. Three were quadriplegics and four paraplegics. Six of the seven had ASIA-classified complete injuries. Ages ranged from 11 to 32 (average 22), and the time between injury and surgery varied from six months to six and a half years. Spinal cord lesions ranged from 1 to 6 cm in length. Most injuries were contusion injuries, similar to those sustained in car accidents.
Although preliminary results are promising, Lima says that much follow-up work is needed to document long-term benefits and any delayed side effects, and patients should have realistic expectations. He believes that even modest restored function can have profound quality-of-life benefits.
Six of the seven patients regained some sensation and muscle control within a month of surgery. The seventh had a second undetected lesion, which led to him not improving. Lima says improvement should gradually continue with time as neurons or their axons further regenerate and grow.
This gradual improvement is demonstrated by Lima’s first patient, a 21-year old female who sustained a C7-T1 contusion-type injury six months before surgery. She regained some sensory recovery about one month after surgery, voluntary abdominal muscle control at two months, some gluteus and leg adductor muscle control, including standing without leg braces after about nine months, and recently some bladder control.
Lima’s patients have had access to only modest post-surgical rehabilitation. He believes maximum restored function will require much more aggressive rehabilitation.
Spinal cord regeneration
The clinical findings were confirmed by the electroneuromyography data which assesses, quantitatively, the muscle response to nervous stimulation. After cell transplantation, there was an increase of the muscle response amplitude to activation of motor nerve fibres of peripheral nerves. This data is indirect evidence that cellular therapy promotes spinal cord regeneration.
In terms of SCIs, there are numerous function-restoring stem cell transplantation programmes that are emerging worldwide. The Healing Therapies website lists seven facilities in Europe, 10 in Asia, one in Australia and four in South America and Mexico, one in the US and Canada. There are literally hundreds more. Which ones have reasonably strong scientific foundations?
Last year a Cape Town couple, American Laura Brown and Steve van Rooyen operated Advanced Cell Therapeutics, previously known as Biomark, a US company investigated by the FDA for making false claims about stem cells. The couple even appeared on the FBI's most wanted list.
In a Carte Blanche programme on 30 July 2006, the extent of the couple's fraud was revealed in an interview with Karl van der Leeden, a former tennis player who suffered from multiple sclerosis. He paid up to R200 000 for a small vial of umbilical cord blood stem cells. At first his recovery was remarkable, but then he deteriorated.
Justine Asher, a 35 year-old paraplegic, paid R120 000, but found afterwards that her procedure had been administered incorrectly.
Andy Sostak’s story is a complete contradiction, however. She is a 39 year-old T12 paraplegic following a car accident five years ago. Two years ago she underwent umbilical cord stem cell treatment at a Holistic Medical Centre in Rotterdam, Netherlands, after much careful research.
The purified cells are injected into the area of the spine where the injury occurred. Stem cells are also infused by intravenous drip for about an hour.
Since then she has experienced a dramatic increase in muscle strength and has regained 100% bladder function. “I believe stem cells are the future, not just for people with SCIs, but for everyone. You have to understand that it’s a process and not a miracle cure. You have to link the therapy to other treatments.” Andy has intensive physiotherapy and keeps her body healthy.
“It is a lot of money, and so much depends on how long you have had your injury, the nature of your injury, your attitude and your wellness. I do believe that the power of my mind and my physiotherapy have been key in my recovery. Do not expect a miracle – only you can make yourself better – but I do advocate it; without a doubt it has made a huge difference to my life.”
Bridget Hall’s son Matthew was a top motocross racer in the country. He sustained an incomplete lesion after a freak accident in 2004 and was rendered paraplegic. He has had numerous therapies since then. However, the most impressive recovery has been from stem cell therapy. In 2005 Matt underwent treatment with umbilical cord blood stem cells from Biomark (now Advanced Cell Therapies) at the Preventative Medicine Clinic in Rotterdam.
While Advanced Cell Therapies has received some bad press, Bridget says their experience of the company was not negative, but professional and very positive.
“Before the treatment, Matt was able to use only his right hand somewhat, and he had no movement or sensation below chest level, except some reflexes and vague sensation in his feet.
After three days he was able to fully extend his right forefinger. Within a week his overall muscle strength increased by up to 45%, including hamstrings and quadriceps. After seven weeks he could get a strong “gooseflesh” response on his back and legs, and after eight weeks he was able to rotate, swivel and tilt his hips about 15 to 20 cm while standing.
Bridget says that additional therapies are vital. “Stem cell therapy is only part of what is needed to make a good recovery. Stem cells are totally untrained in the job of movement and sensation, as they have to learn what to do. The way the new tissue learns is by repetition of the movements you want to do voluntarily.”
Matthew undergoes three hours of intensive physiotherapy and an hour of electrical stimulation every day, occupational therapy twice a week and neurofeedback training every second day for 45 minutes.
Says Bridget: “Remember, this is not a quick spin-off recovery for SCIs. All in all, stem cell therapy has been a wonderful experience and critical in the ongoing recovery of my son.”
Subsequently Matthew has had another injection of stem cells. Within 24 hours his left hand was able to open its last three fingers. He also started yoga, chakra healing and meditation. Two months later he started to move his feet. He was able to wiggle all his toes on his right foot and two weeks later all the toes on his left foot! His bowel is normal and his bladder is almost there.
While driving his hand-control-adapted car last year Matthew found himself unconsciously putting his foot on the brake pedal. He is now practicing accelerator control with his right foot. He continues with all his daily physiotherapies, yoga, etc., and also goes horse riding every week.
Bridget urges everyone with SCIs to go for stem cells as soon as possible. But she adds that physio, exercise, yoga, healthy diet and a positive state of mind are equally important. She stresses that the mind is your most important weapon in healing yourself. Her son Matthew has been taught how to access his creative ‘alpha state’ of mind to instill the idea of healing and walking, and to remove residual trauma from the accident. “See yourself as whole, because that is what your body has a memory of and it can remember that state again.”
Ari has a more conservative view, “I have no doubt that improvement, and maybe a cure, will come from the use of stem cells. Right now, however, I am just not sure that anybody is in a position to declare that there is a cure available.”
Dr Rob Campbell of the Spinal Cord Association of South Africa, and Rolling Inspiration's regular medical columnist, says all regenerative therapies, including stem cells, are still highly experimental. “I do not believe that these therapies should be done anywhere except under controlled conditions in a laboratory.
“Issues such as how much to use, and where to use them, are all still mysteries. We do not know what will get the correct results. And unfortunately I have seen stem cell therapy that has led to cancer and severe meningitis.”
Dr Campbell says that in today's terms, care and rehabilitation of people with SCIs is excellent. With excellent acute care, a large percentage of SCIs improve rapidly. “If you want to improve your condition, rather concentrate on physiotherapy, for example. In the future there will be a place for stem cell therapy and the like, but we are a long way from that time.”
Dr Vicky Longshaw is a post-doctoral research Fellow in the Department of Biochemistry, Microbiology and Biotechnology at Rhodes University, concurs with Dr Campbell. “Stem cells and regenerative medicine have the potential to revolutionise the treatment of disease in a way once never thought imaginable. However, significant technical hurdles remain that will only be overcome through years of intensive research.”
For people with SCIs, the question is still: Do I use my resources and time now or do I wait a little longer for further progress and breakthrough? There are unscrupulous operators who understand the value of ‘hope’ and have exploited the funds and ‘hope’ of people with SCI injuries.” Says Seirlis.
“While the opportunity that stem cells offer is of great interest to us, my message is simply to keep yourself in shape, have a positive outlook on life, get on with life, and make a careful decision with your funds, with your body and with your family, before you take such a bold step.”