Questions concerning stem cell therapies of spinal cord injury
[QUOTE=Mr. W]Dr. Wise how are you I had inquired a few months ago about fetal stem cells and how effective they are in spinal cord injury patients. My question is this, I was injured on february 28, 2007 c6, I am experiencing a whole lot of change in sensation, the most common of them all is pins and needles at the bottom of my feet. What exactly does that mean and is there anything I can do to help with sustaining the muscles in my lower extremity. In addition to that I would like to know if there are any trials scheduled to start in the US soon?[/QUOTE]
Mr. W, I am answering your question you question in the Cure Forum because your question is similar to many that people have asked and many people may want to know answer to a similar question. Let me start from the bottom.
• Are there any trials schedule to start in the U.S. soon?
> While a trial has been announced to transplant cells obtained from embryonic stem cells by the company Geron this coming July, it is intended only for people who were injured within 2 weeks. While the cells were derived from human embryonic stem cells (HESC), they were treated so that they have differentiated into oligodendroglia progenitor cells. These are cells that form myelin. This is a phase 1 trial that is intended to demonstrate safety and feasibility of such transplants.
> The North American Clinical Trial Network (NACTN) is planning a study of riluzole (a drug that blocks glutamate receptors) to treat acute spinal cord injury
> The North American Spinal Cord Injury Network (NASCINet) is planning a study of umbilical cord blood mononuclear cell transplants (UCBMC) and lithium treatment of people with chronic traumatic spinal cord injury (>1 year after injury and neurological stable for 6 months), for people that are between 18-64 years of age, C5 through T10 inclusive. The trial will start recruiting subjects this fall and observe them for 6 months, during which time they will be encouraged to stand for at least one hour per day. In 2010, probably during the summer, the subjects will be randomized to a 6-week course of lithium alone, UCBMC transplants, and UCBMC plus lithium. All will receive intensive outpatient locomotor training for 6-12 weeks and then continue their training as tolerated at home. Followup examinations will be done at 3, 6, 9, and 12 months after treatment.
• What can you do to sustain the muscles in your legs?
> You should be using a standing frame to do weight-bearing, progressing to at least an hour a day. Doing functional electrical stimulation of the muscles of your legs is often helpful in maintaining the muscle bulk. You should minimize the amount of baclofen or other anti-spasticity drugs that you take to inhibit spasticity (increased tone and reflexes). Spasticity and spasms (spontaneous movements) are a free form of exercise. You can do functional electrical stimulation of your legs. Swimming and walking a swimming pool is a form of weight supported walking. Exercise tends to reduce spasticity.
• What do pins and needles at the bottom of the feet mean?
> This depends in part of the presence of sensation else where. This sometimes precedes the recover of sensation in the feet. However, if you are getting these sensations and you are not getting any recovery of sensation elsewhere, this may suggest that you are getting what is a form of neuropathic pain. These are feelings that people get, often in areas of the body where they have no touch or pain sensation. These are spontaneous sensations that result probably from activity in your spinal cord neurons. These sensations are akin to the “phantom” pain that people get in their feet after they have injured their nerves to their feet or have had amputations. In other words, the sensations may not come from your feet.
• Fetal stem cells and how effective are they for spinal cord injury?
> Fetal stem cells come from fetuses, either from after abortions or from the amniotic fluids surrounding the fetus. Among the first cell transplants tried for animal models of spinal cord injury, starting in the 1980’s, many laboratories have suggested that these cells will restore function after in spinal cord injury. However, although many clinics in Russia have tried transplanting these cells into the spinal cord, no convincing clinical trials of such cell transplants have been reported. The reason may be because cells obtained from aborted fetuses are not immune-compatible with the persons that receive the cells. Unless immunosuppression is done, the transplanted fetal cells are usually rejected. This may be why the treatments are not effective. It s important not to mix up fetal stem cells with embryonic stem cells.
> Embryonic stem cells are collected from the earliest stages of development, during the first week or two after fertilization, when the fertilized egg has developed into a tiny ball of cells called blastocysts. This so early that the blastocyst has not yet implanted into the uterus. Embryonic stem cells obtained from this stage of development are often plurpotent (i.e. capable of producing almost all types of cells in the body). Before transplantation, these cells must be differentiated so that they are no longer pluripotent. The reasons is because embryonc stem cells produce tumors called teratomas, tumors that have cells of many types, if they are not pre-differentiated before transplantaton. A few laboratories have reported that embryonic stem cells improve function in the spnal cord after transplantation. However, all these studies have shown efficacy only when the cells are transplanted early after injury. The Geron trila will be testing human embryonic stem cells that have been differentiated to oligodendroglial progenitor cells, cells that myelinate axons.
> Induced pluripotent stem cells. Recent studies by Yamanaka, et al. in Kyoto, Japan and by Jamie Thomson and colleagues at the University of Wisconsin have reported that introducing four genes can convert adult skin cells into pluripotent embryonic stem-like cells. These are called IPS cells and several studies have reported that such cells are beneficial in stroke, Parkinson’s disease, and spinal cord injury. Because these cells could be induced from the person’s own cells, they are immune-compatible and are unlikely to be rejected. However, the cells tend to produce tumors and a lot of safety studies are needed before these cells can be tested in human clinical trials.
• How about overseas? Several centers are offering a variety of stem cell therapies overseas.
> A Dr. Geeta Shroff in Delhi, India has been offering human embryonic stem cells treatments to people with spinal cord injury and other conditions. Her claims are not credible and it is not clear what cells she has and is actually injecting. Most doctors are very skeptical about her claims. Some people who have been treated by her believe that the cells have helped them. On the other hand, many have gotten little or no improvement.
> A Dr. Carlos Lima in Lisbon, Portugal, has been offering olfactory mucosal transplants. The lamina propria layer of the olfactory mucosa contains stem cells and olfactory ensheathing glia. While Dr. Lima reports that he is seeting beneficial results, most doctors are franly skeptical that these treatments are doing anything for the patients.
> A Dr. Hongyun Huang in Beijing offers fetal olfactory ensheathing glia (OEG), which are not stem cells. It is not clear that these cells are doing much to restore function to people when administered intrathecaly (i.e. into the cerebrospial fluid surrounding the spinla cord. Fetal OEG, however, may restore some sensory function in people with spinal cord injury.
So, in summary, there are currently no clinical trials that are being planned from fetal stem cells in chronic spinal cord injury, at least not in the United States. There is one trial that is being planned for embryonic stem cells for people with subacute (<2 weeks after injury) spinal cord injury, using oligodendroglial progenitor cells, derived from human embryonic stem cells. Several trials are being planned for therapies, including umbilical cord blood cells. Several overseas clinics are selling embryonic, fetal, and umbilical cord blood stem cells. Most of these places are very controversial, not respected, and not credible.