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Respected Dr. Wise Young,
> How are you Dr. Young? I am one of your facebook friend. My spinal
> cord was fractured at L1 about 20 years ago. I am 48 now. My case is
> paraplegic.
> I had heard a news about stem cell trials going on in Geron company in
> Sept 2010. I don't know what is the progress w.r.t. these trials now.
> Is there any hope for us. Persons with SCI are living a painful life
> due to unablility to move, urinate and defaecate.
> Is there any more researches elsewhere also getting positive and
> hopeful results on the treatment of spinal cord injury?
> I request you to make me known about the recent results of trials,
> researches and experiments that are showing hopeful results with
> regards to spinal cord injury, especially old cases of SCI like that
> of mine.
> In particular I would like to know about the trials on SCI going on in
> Geron Company.
> I would be very greatful to you for providing me valuable informations.
> Thanks!
Much has been going on in terms of cell transplant therapies for spinal cord injury. Let me summarize the progress of different trials:
In 2010, Geron started the first clinical trial of human embryonic stem cells. Geron's trial is only for people within 2 weeks after injury and is a phase 1 trial, i.e. one that is looking at safety. As you know, they are transplanting oligodendroglial progenitor cells derived from a human embryonic stem cell line. To my knowledge, they have transplanted the cells into the spinal cords of two patients to date and the results of the trial are not likely to be available at least until next year.
ChinaSCINet is assessing effects of umbilical cord blood and lithium on people with chronic spinal cord injury, we have tested increasing doses of the cells 7 patients in Hong Kong, hopefully our 8th patient will be done in August. In the meantime, we are starting the same trial in Kunming, China, where there are more patients and should progress faster. When data is available from these two trials, we will apply for permission to carry out phase 3 trials in China and the United States in 2012.
Bioaxone's Cethrin had shown promise when applied within 2 weeks after injury, converting over a third of patients who are ASIA A into ASIA B or C. Cethrin is a modified bacterial toxin that blocks an intracellular messenger called Rho, known to mediate the effects of growth inhibitors on axon growth. It was licensed by Alseres. Unfortunately, Alseres could not raise the money to do further trials and returned the license has been returned to Bioaxone who is now trying to raise money for trials.
Novartis has apparently completed phase 1 trials assessing a human Nogo antibody. Martin Schwab discovered that antibodies against Nogo, a myelin protein, stimulates regeneration in the spinal cord of animals. Novartis licensed the technology from the University of Zurich. Novartis is deciding whether or not to continue onto phase 2 or phase 3 trials. Note that the treatments have been given to people within weeks after spinal cord injury.
Stem Cell, Inc. recently announced a clinical trial in which they are transplanting a neural stem cell line into the spinal cord at 6 months after spinal cord injury. In this phase I trial, they are first transplantating the cells into spinal cord of four patients that are ASIA A (complete) spinal cord injury, then three patients that are ASIA B (sensory incomplete), and then two patients that are ASIA C (motor incomplete). This trial is intended to establish the safety and feasibility of such transplants.
Several groups are evauating intrathecal bone marrow stromal cell transplants. A Cairo group and Alok Sharma in Bombay have transplanted autologous bone marrow stromal cells into several hundred patients. While, both groups have reported improvements in patients, these trials have not been controlled and the data is not yet convincing. Dozen of clinics around the world are now offering intrathecal transplantation of autologous bone marrow cells around the world.
In Jordan and Dubai, two groups have been transplanting autologous CD34+ bone marrow cells directly into spinal cords of people with chronic spinal cord injury. Based on presentations that I have seen of these studies, the patients have had some sensory and motor return but these are not controlled studies and it is not clear how much of the recovery were due to the surgery alone. Also, long-term followup studies are not yet available.
In China, Hongyun Huang has published reported indicating experience transplanting fetal olfactory ensheathing glial (OEG) cells into the spinal cord and brains of over 1600 patients with spinal cord injury and other conditions. Four other groups in China have published smaller series of OEG transplants into spinal cord injury that confirm that the transplants may improve sensory function but have limited motor effects. Unfortunately, none of these trials have been controlled and most doctors around the world are not convinced of the results. On the other hand, even though uncontrolled, these trials strongly suggest that transplantation of cells into the spinal cord does not cause loss of motor or sensory function.
So far, OEG transplants have not yielded impressive motor recovery. This may be because the cells come from aborted fetuses and are not matched (HLA or otherwise) with the recipients. Animal experiments indicate that OEG cells are rejected from the spinal cord within weeks after transplantation. This may explain why there is an initial spate of sensory improvement during the first few weeks and then no more improvement after that. This may be true of all fetal cell transplants, which are not matched with the recipients and therefore are likely to be rejected.
To get around the problem of heterologous (i.e. non-HLA-matched or allogeneic) olfactory ensheathing glial cell transplants, several investigators have tried to obtain OEG cells from the same person. There are two potential sources of autologous OEG: the nasal mucosa and the olfactory bulb. Several groups claim to have grown OEG cells from nasal mucosa. Drs. Alan McKay-Sims and Tim Geraughy in Brisbane, Australia reported isolating olfactory ensheathing glia from the nasal mucosa of 2 patients and transplanting them into the spinal cord injury site. They did not find significant functional improvement. Dr. Carlos Lima from Lisbon in Portugal transplanted nasal mucosa into the spinal cords of about 160 patients with chronic spinal cord injury. He has reported the outcomes of a relatively small number of subjects. The recovery appears to be limited although Lima recently published a study reporting motor recovery in patients who engage in intensive motor exercise for years after the transplantation.
Three groups have been making questionable claims. Geeta Shroff of Delhi, India, claims to be transplanting embryonic stem cells but has provided no data concerning the origin of the cells or treatment results other than news reports. Another is Beike Biotechnology, which advertises non-HLA-matched CD34+ umbilical cord blood cells infused for intravenous or intrathecal administration into patients with chronic spinal cord injury and other conditions. Finally, X-cells in Germany processes bone marrow cells and the cells are then transplanted into the patients by doctors in Germany. X-cell was recently closed by German authorities.
In my opinion, these groups are making false claims concerning the efficacy and safety of their therapies.
In summary, many cell transplant trials are going on around the world. The Geron trial is transplanting oligodendroglial progenitor cells into subacute spinal cord injury (2 weeks after injury). ChinaSCINet is evaluating HLA-matched mononuclear cells and lithium treatment of chronic spinal cord injury (>1 year after injury). Stem Cells, Inc. is transplanting neural stem cells (human fetal cell line) into the spinal cord of patients at 6 months after injury. Several groups in China have been transplanting human fetal olfactory ensheathing glial cells. Several groups in China and the Middle East have been transplanting autologous bone marrow into the spinal cord. Many groups in China, India, Jordan, and Egypt have been transplanting autologous bone marrow cells intrathecally. To date, I don't think the data is convincing yet that any of these transplants are bringing back function. There is not yet sufficient information to recommend any of the cell transplants. We need more trials of combination therapies.
I hope that this is helpful.
Wise.
"
Theres a lot more that has to be done but at least something is happening.
ps. sci1998 you are not welcome to post in this thread. We dont need another pointless discussion.
Edited by love&hate, 03 August 2011 - 05:22 PM.
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