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Thread: Doctor (Young) Seeks Spinal-Therapy Trials in China

  1. #21
    Hey Dr. Wise How do you sign up for a clinical trial?

  2. #22
    Dr. Young,
    Outstanding reply . I hope that every here has the opportunity to read this in-depth review. Your dedication is remarkable and will hopefully be recognized with the Noble Prize someday.
    Respectfully yours,
    James

    Quote Originally Posted by Wise Young
    James,

    I only know what Dr. Huang has published and has told me verbally. He has published a paper in a Chinese journal which described the first 171 (or thereabouts) cases that he did, using the original procedure of doing a wide multi-segmental laminectomy to expose the spinal cord and transplanting the fetal olfactory ensheathing glial cells. That study reports significant improvements in both sensory and motor ASIA scores. At that time, he had only 3 mortalities that he knew about, all occurring more than 3 months after surgery and from causes such as pneumonia and apparently unrelated to the surgery.

    I don't have any information about additional mortalities in people with spinal cord injury. He has had a number of mortalities in people with ALS (amyotrophic lateral sclerosis) that he has transplanted fetal olfactory ensheathing glia to; I have heard of at least 3 cases but there may have been more. However, as people know, ALS is a progressive disease that leads to death in over 90% of people within 5 years of the diagnosis and many of the ALS cases that Dr. Huang transplanted to were quite advanced.

    Regarding other complications from surgery, Dr. Huang has told me (and I have seen) fever in many of his patients after surgery. Dr. Huang believes that this is a common sequelae of exposing the spinal cord and allowing cerebrospinal fluid to drain. I know that Dr. Jim Guest from Miami had visited Dr. Huang and saw fever in several of the patients. He thought that it was due to meningitis (inflammation of the meninges that might include infection) although I think that the evidence for this is very limited. The extent to which the fever is due to just the surgery, the implantation of non-matched fetal allografts, or other causes is not clear. Dr. Huang generally treats the patients with non-steroidal anti-inflammatories and antibiotics. To my knowledge, no spinal cord injury patient has died of meningitis after surgery while in hospital with Dr. Huang.

    Most of the patients seem to have a headache for several days after surgery. This is a common sequelae of surgery that exposes the spinal cord and allows cerebrospinal fluid drainage. Of course, some of the patients have had other complications of surgery including urinary tract infections. I met several patients who said that they had increased neuropathic-like pain for several weeks, in the regions where they are recovering sensation. I know of one person who had neuropathic pain before the surgery and the pain may have gotten worse after the surgery. However, I also know of at least one patient whose neuropathic pain largely went away after the surgery. I have not met anybody who did not have neuropathic pain before and then developed significant neuropathic pain that remained for more than several weeks.

    Most patients who have received the transplant have had some improvement in sensation, typically four or more dermatomes below the original injury site. Motor recovery has been more variable and modest, typically averaging one segmental level but occasionally more. In the 10-20% of patients who are in the Beijing area and who return for followup, the gains in both sensory and motor recovery appear to be sustained for a year or more. Several of the patients who had limited voluntary function below the injury site before the surgery may have gotten back sufficient function to stand and take some steps but it is difficult to know whether this is related to the surgery or the post-operative attempts by the patients to walk. Perhaps the most striking and consistent improvement in function has been better balance of the trunk. I have seen several patients recover ability to sit in bed without support.

    Many people, including myself, have strongly urged Dr. Huang to carry out a randomized clinical trial to show that the treatment is effective. He has responded recently by planning a clinical trial comparing fetal Schwann cell transplants and fetal olfactory ensheathing glial cell transplants to patients. I believe that he is also planning to compare these two against transplantation of a mixture of Schwann and olfactory ensheathing glial cells. In my opinion, this is a logical way for him to go. In China, it would be impossible for him to do a controlled clinical trial with sham surgery and I don't think that Dr. Huang believes that this is ethical. So, a comparison of different cell transplants seem to be the logical way to go. Since he has the cells from the aborted fetus, he can transplant olfactory ensheathing glia, Schwann cells, or a mixture of the two cells isolated from the fetus. If he finds that one or more of the treatments are significantly better, and the patients are better than before surgery, this would be a strong argument for the efficacy of the treatment.

    Dr. Huang's planned OEG/SC/OEG+SC clinical trial is not part of the ChinaSCINet. Dr. Huang's center will participate in the clinical trial involving umbilical cord blood and lithium that we are planning, if his center obtains all the certifications to do so. The ChinaSCINet decided against doing a fetal cell transplantation trial because of the difficulty of getting the cells in sufficient numbers for all the participating centers and also because the lingering questions concerning immune-rejection of non-HLA matched fetal cells. Please note that Dr. Huang's center is not the only one that is carrying out other therapies besides the one that ChinaSCINet is planning. For example, several other ChinaSCINet centers are transplanting fetal Schwann cells (Kunming), adult Schwann cells autografts (Tianjin), fetal olfactory ensheathing glia (Xi'an, Beijing Army General), adult bone marrow autografts (Zhengzhou). I do hope, however, that our extensive training of all the centers have contributed to standardization of neurolological examinations and data collection, as well as followup in all the centers.

    Finally, I have consistently recommended to people that they wait. The reason is that I don't think that the procedure at the present is producing sufficient recovery of motor function to warrant going to China for the surgery. I believe that the procedure and the treatment will improve with time. In addition, I think that the best therapy will be a combination of the cell transplants with growth factors and growth inhibitor blockade. Our clinical trial of umbilical cord blood mononuclear cells and lithium will hopefully test the first combination of cell transplant with lithium to stimulate growth factor expression by the transplanted cells. If this works, this is something that Dr. Huang can use with his OEG transplants (we have some preliminary animal data suggesting that lithium also simulates growth factor production by OEG cells). These possibilities need to be confirmed in animal studies and tested rigorously in clinical trial before I can recommend them.

    Wise.

  3. #23
    Nice answer, Dr. Young !

    Quote Originally Posted by MiamiProjectJames
    Dr Young or any member,
    Can you share the findings of the other 99% of the people who other recieved these treatments? The best case & worst case; # of deaths?

    Since 2001, Dr. Huang has performed these procedures on more than 700 people, charging $20,000 per treatment.

    "The study says none of seven spinal-injury patients observed experienced significant improvements, with five suffering potentially dangerous complications."
    "None of seven spinal-injury patients observed experienced significant improvements, with five suffering potentially dangerous complications"? Um, interesting!

    As I know there was short news on the website at http://www.nrrfr.com/english_nr.asp?newsid=789&bt=News regarding Dr. Dobkin's paper. Why it seems that Dr. Dobkin's observation is different from patients and their relatives' description?

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