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Thread: Huang: Safety and factors influencing recovery in SCI patients after OEC transplants

  1. #1

    Huang: Safety and factors influencing recovery in SCI patients after OEC transplants

    Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2006 Apr;20(4):439-43.Related Articles, Links

    Safety of fetal olfactory ensheathing cell transplantation in patients with chronic spinal cord injury. A 38-month follow-up with MRI.

    Huang H, Chen L, Wang H, Xi H, Gou C, Zhang J, Zhang F, Liu Y.

    Neurological Research and Treatment Center, Beijing Xishan Hospital, Beijing, 100041, PR China. hongyun@mailcity.com

    OBJECTIVE: To determine the safety of the fetal olfactory ensheathing cell (OEC) transplantation in patients with chronic spinal cord injury (SCI) by examination of the magnetic resonance imaging (MRI). METHODS: A prospective clinical study involving 16 patients with chronic SCI was designed to investigate the feasibility and biological safety of the fetal OEC transplantation in treatment of SCI. The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use. From November 2001 to December 2002, 16 patients with chronic SCI were randomly enrolled. The patients suffered from SCI for 1.5-8 years (average 4.3 years) after the injury. The suspension (50 microl) containing about 1 x 10(6) fetal OECs was transplanted by an injection into the patients' spinal cords above and below the injury site. All the patients were assessed before the transplantation and were followed up with MRI for 29-42 months (average 38 mon) after the transplantation. RESULTS: No cell-related adverse effects were observed in any patient during the follow-up period. The follow-up with MRI did not reveal any development of optic glial tumor, tumor-like mass, new hemorrhage, edema, expanding cyst, new cyst formation, infection or disruption of the neural structure in the transplant site of all the patients. CONCLUSION: This is the first clinical study demonstrating the long-term safety of the OEC therapy for SCI. The results indicate that our protocol is feasible and safe in treatment of patients with chronic SCI within 38 months after the injury. Although the size of the samples for our study was not big enough, the positive results of the study have encouraged us to make a further research in this field.

    PMID: 16683452 [PubMed - in process]
    Last edited by chenchina; 05-12-2006 at 06:01 AM.

  2. #2

    Influence factors for functional improvement after OEC transplanting for SCI

    Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2006 Apr;20(4):434-8.Related Articles, Links
    Influence factors for functional improvement after olfactory ensheathing cell transplantation for chronic spinal cord injury.

    Huang H, Wang H, Chen L, Gu Z, Zhang J, Zhang F, Song Y, Li Y, Tan K, Liu Y, Xi H.

    Neurological Research and Treatment Center, Beijing Xishan Hospital, PR China. hongyun@mailcity.com

    OBJECTIVE: To explore the influence factors for the functional improvement after the fetal olfactory ensheathing cell (OEC) transplantation for chronic spinal cord injury(SCI). METHODS: The olfactory bulbs were harvested and trypsinized down to single fetal OEC. They were cultured for 12-17 days prepared for use. From November 2001 to December 2003, a total of 300 patients volunteered for the fetal OEC transplantation, among whom 222 suffered from complete chronic SCI and 78 suffered from incomplete chronic SCI. The procedures were performed on the patients with a disease course ranging from 6 months to 31 years (average 3.1 years) after their injuries. The fetal OEC was transplanted by the form of injections into the spinal cord at the upper and lower ends of the injury site. All the patients were assessed by the ASIA standard before the transplantation and 2-8 weeks after the transplantation. The influence factors including age, sex, duration after the injury, and injury degrees and levels were compared with those in the functional improvement after fetal OEC transplantation. RESULTS: The partially-improved neurological functions assessed by the ASIA standard were indicated by the motor scores increasing from 39.1 +/- 20.6 to 45.9 +/- 20.3 (P < 0.001), the light touch scores from 51.7 +/- 24.9 to 63.4 +/- 23.0 (P < 0.001), and the pin prick scores from 53.0 +/- 24.2 to 65.3 +/- 22.7 (P < 0.001). There was no significant difference in the functional improvement of the motor, light touch, and pin brick when compared with the age, sex, duration after the injury, and the injury degrees and levels. The motor scores and light touch scores at the cervical level were higher than the scores at the thoracic level. CONCLUSION: The fetal OEC transplantation can partially improve the neurological functions quickly in treatment of the chronic spinal cord injury. All the influence factors except the motor scores and light touch scores, which were higher at the cervical level than at thoracic level, have no impact on the functional improvement after the fetal OEC transplantation.

    PMID: 16683451 [PubMed - in process]

  3. #3
    chenchina, thank you very much for posting. I merged the two papers into one thread so that they can be discussed together.

    For people who are not familiar with the terms, here is a glossary:
    Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi is the Chinese Journal of Reparative and Reconstructive Surgery
    Olfactory Ensheathing Cells. These are cells that are continously produced in the lamina propria in the nose throughout life. These cells migrate in the olfactory nerve (the nerve the carries the sense of smell) to the olfactory bulbs (the central nervous system structures that process smell information).
    ASIA. The acroynm stands for the American Spinal Injury Association. The ASIA classification and neurological scoring system was established in the 1980's and was accepted as the International Spinal Cord Injury Classification system in 1990 by the International Spinal Cord Society and most major clinical societies. See http://www.asia-spinalinjury.org/pub..._worksheet.pdf
    Motor scores. These are scores of motor strength. A total of 10 muscles on each side of the body are graded on a scale of 0-5 and added, for a total score of 100. 0 is paralysed, 1 is slight movement, 2 is visible movement, 3 is movement against gravity, 4 is movement against resistance, 5 is normal strength.
    Sensory scores. Each dermatome (the area of skin innervated by one spinal cord segment) is scored on a scale of 0-1 and added together for a total of 112 points. A total of 112 points are possible for light touch and 112 points for pinprick (pain).
    Variance. The paper gives mean (average) motor and sensory scores, including plus/minus or +/- signs indicating the standard deviation of the scores. The "P < 0.001" is a statistical term indicating that the probability of these results occurring by chance is less than 1 in 1000.
    Number of cells transplanted. The number 1 x 10(6) means 1 million cells. A million cells were injected above the injury and another million cells were injected below the injury site.
    Complete and incomplete. According to the ASIA standards, a complete spinal cord injury is defined as having a level below which there is complete loss of motor function. Practically, this definition means a person who at minimum has no motor function (voluntary sphincter contraction) or sensory function (touch or pinprick sensation) at the anus, since this is the lowest level of the spinal cord.

    I think that the abstract translation left something to be desired. For example, the safety paper referred to "optic glial tumor". I am not sure that they meant optic glial tumor. Perhaps they were referring to olfactory glial tumor.

    Wise.
    Last edited by Wise Young; 05-12-2006 at 07:24 AM.

  4. #4
    As some here on this site know, Dr. Hongyun Huang trained with me and has transplanted fetal olfactory ensheathing glial cells into hundreds of people with chronic spinal cord injury from 2001 to now. I have examined some of his patients and many of the patients have shown sensory improvement, some motor improvement, and better truncal responses. I have urged people to be patient. This treatment is not a cure.

    In recent months, there have been several very critical articles written about Dr. Huang. Many of these articles have accused him of not publishing his data. I know that he has been trying hard to get his data published in western journals. On the other hand, this is a respected Chinese journal and its publication suggests that at least some of Dr. Huang's colleagues in China believe that this work is worthwhile publishing. Many Chinese doctors have difficulty publishing their clinical results in western medical journals.

    By the way, it is not easy to get published in a Chinese medical journal. There are probably more doctors in China than in the United States and Europe combined. In recent years, the scale of scientific research and clinical trials in China has grown tremendously. Many doctors and scientists are trying to get their work published. So, I am glad that this work is finally published.

    Wise.

  5. #5
    Dear dr Young

    In few sentences, this is situation: my wife suffered an SCI in 93, the injury is incomplete at the T12 , L1 level. He make some progress in recovery, walk with prostetic at the legs and a walker. We heard about dr Huang from Beijing and Dr Yang from Beike (Shenzen). I see here on this forum and on the http://www.stemcellschina.com different opinions.
    What can we do ? Were can we go ?
    I know can be very dificult for you, to do this answers , but please help us

    Thank you in advance

    Adi

  6. #6
    Quote Originally Posted by aditzu
    Dear dr Young

    In few sentences, this is situation: my wife suffered an SCI in 93, the injury is incomplete at the T12 , L1 level. He make some progress in recovery, walk with prostetic at the legs and a walker. We heard about dr Huang from Beijing and Dr Yang from Beike (Shenzen). I see here on this forum and on the http://www.stemcellschina.com different opinions.
    What can we do ? Were can we go ?
    I know can be very dificult for you, to do this answers , but please help us

    Thank you in advance

    Adi
    Adi,

    I understand the difficulty of your decisions. As I have said many times before, none of the treatments are offering a cure. It is important, however, that your decisions are based on real information of real improvement. I don't think that I have seen anything from Beike that is yet convincing that it is producing significant functional recovery in any person with spinal cord injury and there is not enough information about the procedure and what it does that would justify going there. While the OEG transplants may be producing some improvements in some people, people will have to decide whether that is worthwhile or not. Again, I would recommend patience.

    Wise.

  7. #7
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    Dr. Huang Report

    The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use ( Quote )

    Dr. Wise. Some weeks ago I commented that the Congress would not pass any legislation that would permit the usage of stem cells which came from aborted fetuses. You corrected me about the stem cells and their relation to the fetuses. Seeing this new post today leaves me rather confused as to your original correction. Could you please clarify if you would like.

  8. #8
    Quote Originally Posted by eagle18
    The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use ( Quote )

    Dr. Wise. Some weeks ago I commented that the Congress would not pass any legislation that would permit the usage of stem cells which came from aborted fetuses. You corrected me about the stem cells and their relation to the fetuses. Seeing this new post today leaves me rather confused as to your original correction. Could you please clarify if you would like.
    Eagle, I don't remember what I originally said and unfortunately don't have the time to look it up but I don't think that I have expressed my personal opinions concerning use of fetal stem cells but simply tried to point out the facts.

    I may have corrected you to point out that Congress in fact has passed a law that says that NIH can fund research on cells obtained from aborted fetuses. Furthermore, the Supreme Court has ruled that abortion is legal in the United States, if it is done before the time when the fetus would be viable. Thus, your statement that "Congress would not pass any legislation that would permit the usage of stem cells which came from aborted fetuses" is not true. They have already done so.

    There is a company called Stem Cells, Inc. that is developing stem cell lines that come from aborted fetuses for therapy (Source). They would not be doing so if use of fetal stem cells were illegal in the United States. Hundreds of patients with Parkinson's disease in the United States have received transplants of dopaminergic neurons that have been isolated from aborted fetuses.

    Wise.

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