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Thread: OEG Treatment of ALS

  1. #11
    The following is an email from a person who has a family member with ALS

    My friends told me "there is a hope for your brother-in-law, since they saw CBS news last week, showing Dr. Huang in China successfully treated ALS with fetal cells ". After I told them my brother-in-law had had this treatment by Dr. Huang already, and currently he is in critical condition...", my friends encouraged me to write it out to share our experience with the others, it may help other PALS in the world.

    My brother-in-law ZJ, 67 year old doctor in Shanghai, was diagnosed to have ALS in June last year after developed slurred speech. He was put on Rilutek and many other medications, but his ALS continued progressing. He was confined in a wheechair, communicated with hand writing, and got nutrition from a gastric tube in May 2004. All of us wanted to help him, hoping he can live longer and better. A ray of hope found from the web, we made every effort to contact with Dr. Huang and sent ZJ to him in June, after contacting with Jan, the first American PALS treated by Dr. Huang.

    We paid the amount money as requested (about ZJ's 4 year salary)upon being admitted. ZJ and his wife GYZ (a doctor in a Shanghai Factory) stayed in the hospital, awaiting for the OEG cells. On day 10,the day before the procedure, one man came to the room, asking a cash of RMB$9,000. He said ZJ will have 3 holes tomorrow in the head, each hole will receive OEG cells with a cost of RMB$3,000, a total of RMB$9,000. GYZ gave him the money (about her 12 month salary), requested a receipt. But the answer was "no". GYZ was puzzeled and asked Dr. Huang and Ms. Gao, an incharge nurse in Dr. huang's team. The answer was "We don't give receipt for these, you can not get reimbursement anyway."

    After the OEG cell transplant surgery, ZJ was successfully extubated on the same day, but was extremely irritated. He received sedation. There was no any improvement of his motion activity, and the whole condition appeared to get worse. GYZ was afraid that ZJ may not be able to be back home in Shanghai, and asked Dr. Huang if ZJ can D/C earlier than that had planed (one month after surgery). Dr. Huang agreed.

    From Dr. Huang's hospital, they directly headed to Shanghaiupon. Upon arriving in Shanghai, ZJ was found to be in deep drowseness and sent to Zhong Sang Hospital by ambulance. In the ER, he was diagnosed to have severe hyponatremia with a blood Na+ of 113 (life-threatening level), a severe complication from neuro-surgery secondary to neuro-endocrine (hormone) disturbance. In addition,ZJ was also found in toxic shock secondary to pneumonia...Currently he is still in ZS hospital (ICU). He can no longer sit in a wheelchair, no longer comunicate with hand writing, and ventilated with a trach.

    When the family asked Dr. Huang by e-mail: why such severe complications had happend, and left undiagnosed and untreted. Dr. Huang's reply was "your family did not give enough food through his gastric tube".

    Actually, Ms. Gao, the incharge nurse of the team, said they had treated ALS with OEG cells for a total of 33 PALS by April 2004, there were 3 PLAS gone (died) soon after the surgery.

    We are now in deep grief and only can continue praying for ZJ. Thanks to our frieds who adviced me to write it for all the PALS to share.

    We also regret that we did not carefully consider it before letting ZJ go to Beijing for the treatment. Actually, my wife who works in a hospital in MA, had consulted a Neurologist there. I now copy it below for your reference. I have to erase his name since we have not asked his permission. But we now realize the truth of his letter, and would like to share with you, too.

    Richard

    (The following is a copy of a mail from a neurologist's consultation in MA, USA, in April 2004).

    -------
    Hi, Dear XXX:
    I wish I could share in the enthusiasm; however, the details posted do not permit an informed opinion.

    Most people in the field of treating patients with ALS who wish credibility for their treatments observe certain principles of protocol design, that permit readers of their results to evaluate them. Included in these are use of disease-appropriate standardized measures of outcome,and application of the measures by people who are masked to treatment status (even if it is impossible to have the patient also masked to treatment status).

    Adherence to these expectations does not increase the costs to patients to any significant degree, if the treatment is surgical.

    Furthermore, in the US individuals who are performing experiments on patients would be required to follow very specific protocols, with external oversight, to safeguard present and future patients, and to make sure all relevant data are made public. They would not be permitted to charge patients for treatments until they demonstrated their benefits (magnitude, range, percent of patients benefiting) and understood their risks.

    I'm sorry I cannot be more encouraging with the information I have.

    XXXX

  2. #12
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    ANY help giving us some more time with my brother will do ! We do not have other options. Please Dr Prof Huang, could you respond to my mail I've send you about wanting to help my brother ? He desperatly needs you to confirm.
    My family is in distress and patients with bulbar ALS do need to be stabilized as quickly as possible. They just don't have that much time...

    Originally posted by Huang Hongyun:

    I strongly need tell some things to patients with ALS who want to come for our procedure.
    1. We can't guarantee that patients who will get our procedure can keep function stable forever; we even can't tell how much they can get from our procedure.
    2. From our experience, some earliest patients we did treatment about one and half years still keep function stable; but some other ones only kept functional stable for 3-6 months. We only can prey for them to keep function stable as long as possible after our procedure. We can't forecast how long they can keep function stable both before and after our procedure.

    Huang, Hongyun
    Caro

  3. #13
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    Please could anyone tell me if these transplantations in Nanjing, China and Italy are the same as these from Dr Huang in Beijing ? And could anyone give me the adress in Italy ?
    Thanks!

    [QUOTE]Originally posted by Wise Young:

    OEG Treatment of SCI vs. ALS

    [QUOTE]
    5. I had attached some information of stem cell transplantations for ALS patients done in NanJing, China, and Italy. In all these trials including OEC transplantation, the benefit and improvement seems to occur very quickly after the operation. Could this be due to the trauma caused by the operation or the cells implanted?

    Caro

  4. #14
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    Dear Caro:
    We do OEC or OEG transplantation, not stem cell transplantation. Our procedure is totally different from Nanjing and Italy.
    Thanks!
    Huang,Hongyun
    [QUOTE]Originally posted by Caro6:

    Please could anyone tell me if these transplantations in Nanjing, China and Italy are the same as these from Dr Huang in Beijing ? And could anyone give me the adress in Italy ?
    Thanks!

    [QUOTE]Originally posted by Wise Young:
    OEG Treatment of SCI vs. ALS

    5. I had attached some information of stem cell transplantations for ALS patients done in NanJing, China, and Italy. In all these trials including OEC transplantation, the benefit and improvement seems to occur very quickly after the operation. Could this be due to the trauma caused by the operation or the cells implanted?

    Caro
    Huang, Hongyun

  5. #15
    Dear Caro,
    this is Dr.Mazzini's mail address in Torino:MazziniI@libero.it.
    Write and she will give you all informations you need.

  6. #16
    blu stellina, thank you very much.

    Caro, Letizia Mazzini is at the Department of Neurology at the University of Torino. According to a paper that she and her colleagues published in 2003 (see abstract in the Neurodegeneration forum), they apparently obtained bone marrow cells and grew stem cells from these cells and then injected them intrathecally into 5 patients with ALS. They pointed out that that the procedure appears to be safe and well-tolerated by ALS patients and that none of the patients got worse. They pointedly did not say that the patients got better from the therapy. Silani, et al. (2004) refers to the study by Letizia Mazzini and says that "stem cell therapy will need to be used with other drugs or treatments, such as antioxidants and/or infusion of trophic molecules.

    Regarding the clinical trial in Nanjing, I only have indirect descriptions of the work there and their web site. According to information that KZ (the person who sent me the above question):
    Additional Information of Stem Cell for ALS

    Following is a translation of information regarding the transplantation found in the web site of No. 454 Hospital in Nanjing, China.
    (According to the doctor I spoke to in Nanjing, about 50 to 80 ml bone marrow is drawn from hip. The volume of stem cells solution/suspension after the separation is about 1.5 ml to 2 ml. There is no regrowth of stem cell before transplantation. The detail of procedure is not available.)

    The Transplantation of the Patient's Self Bone Marrow Stem Cells to Treat Motor Neuron Disease

    Methods: The stem cells from the patient's bone marrow is processed and injected back into patient's central nervous system (spinal cord). The patient is also given the cell membrane stabilizer and nerve nutrition drug.

    Effect: 38 cases of self bone marrow stem cells transplantation have been carried out from October 28 to December 5 in 2003; of which one failed to get in touch with us, one had no effect; three have no evident effect because the time between the transplantation and this report is too short, the rest have shown different degree of improvement in the symptom. This manifests mainly in: 1. Speaking becomes rather distinct than before transplantation. 2. Swallow has improved. 3. The power of gripping has increased. 4. The ability to stand and walk has been enhanced. These changes mostly appeared from one day to within a week after the transplantation. None of patient shows progression of symptom after transplantation. The short term curative effect is good but the long term one remains to be proved by time.

    Analysis: The fact that patients start to show improvement in their symptom within one week after the transplantation indicates that the cell factors excreted by the transplanting cells have a curative effect on the motor neuron. For a patient, the stem cells existing in his bone marrow can not prevent the motor neuron disease from developing, but the same stem cells once transplanted into the central nervous system are able to have a curative effect on the motor neuron disease. This phenomenon has shown that the cell factors which are excreted by the bone marrow stem cells and provide nutrition support to the motor neuron fail to enter into the brain and spinal cord and the most likely cause of this failure is that the function of transferring these cells by the blood - brain barrier has been obstructed so that the motor neuron become gradually degenerate and die because of nutrition shortage. This cause of the motor neuron disease is what we infer from the clinical treatment, but much work remains to be done to verify this theory. A longer time observation is needed to see whether the bone marrow stem cells can grow into the motor neuron and further their curative function.

    The Merits of the Self Bone Marrow Stem Cells Transplantation: It avoids two major difficulties: ethical problem and immunology repellence. Theoretically, the transplanted own stem cells can live better, propagate and differentiate in the patient's central nervous system, and can possibly have a long term curative effect.

    Typical Cases:
    1. Male, age 56. After transplantation the gripping power of his both hands increases by 2 kg, the muscle strength of his both lower limbs rises from 0 level to 2 level, and the symptom of his swallow difficulty has lessened.
    2. Male age 68. He had difficulty in lifting his pants with both his hands before surgery. Five days after the transplantation he can raise his pants at ease and his both hands can reach the back of the body to lift the pants.
    3. Male age 60. His right hand could only touch his forehead when combing his hair. Six days after transplantation, his right hand is able to touch his rear occipital.
    4. Female age 54. Before the surgery, she could only make a phone call with others holding the phone for her and relieve herself with the help of her family members. But three days after the transplantation, she can call her family members with right hand holding the cell phone for several minutes and lift her own buttocks by herself when the bed pan is placed under her.
    5. Male age 52. He could only turn over in bed with the help of the attendants. After the transplantation, he can do it by himself and his right hand power of gripping increases from 3kg to 9 kg.
    6. Male age 54. After the transplantation, his right hand grip increases from 0 kg to 2 kg, and his speaking power is evidently increasing. And ten days after the surgery, he can put his hands into his pant pocket, which he was unable to do for more than one year.

    Remarks: The goal of this trial is to prevent the further progression of the patient's condition and strive for a gradual improvement in the symptom. From the above mentioned cases we can see that the treatment has an improvement in the patients' paralysis to a different degree depending on patients own condition, but this treatment does not cure the motor neuron disease nor provide major recovery as the patient would hope in the short term. The long term effect remains to be seen.
    KZ also sent me the following conference report regarding Mazzini's trial
    Followings are from the conference reports regarding a similar trial by Dr. Mazzini in Italy. The abstract can be viewed using the link: http://www.mndassociation.org/downlo...Session_4b.pdf

    14th International Symposium on ALS/MND in Nov. 2003
    ...controversy and surprise
    There was also a presentation on a study to determine the safety and tolerability of stem cells in MND.

    Following the recent publication of Dr Mazzini's paper on a study to investigate the feasibility and safety of administering stem cells to people with MND, Dr Mazzini gave an update on her research in the clinical trials session on the Symposium. From the seven patients that have received stem cells to date Mazzini and colleagues concluded that, " Our results appear to demonstrate that... transplantation of these (stem) cells into the spinal cord of humans are safe and well tolerated by ALS patients".
    As in clinical studies of potential drugs, Dr Mazzini used several standard tests for muscle strength and respiratory function to monitor progress during the study. Data from these measures up to 21 months after and six months prior to receiving additional stem cells were presented. All the patients are still alive, although both muscle strength and respiratory function are declining. One interpretation of the data is that the patients are declining at a slower rate after receiving the additional stem cells. In such a small group of patients, with no controls, it is difficult to say whether any differences in the rate of decline of muscle strength or in respiratory function would be due to the stem cell treatment or to the natural progression of the disease in these individuals. In addition to the clinical study, Dr Mazzini briefly mentioned a study in progress in animal models of MND.

    Dr Mazzini's presentation evoked some robust debate on both the methodology and ethics of conducting such controversial studies. Several eminent clinicians voiced strong concerns about Dr Mazzini's clinical stem cell studies. These echoed Prof Michael Swash's caution in an editorial of the journal in which this study was published " it is inappropriate, in the present state of knowledge, to use stem cells as a therapy in ALS ".

    In the closing session of the Symposium Dr Lucie Bruijn, Science Director and Vice President of ALS Association, named three drugs that may be beneficial in MND. Promethazine, Ebselen and Cetriaxone were identified as a result of a large screening programme in which 75% of the drugs licensed by the FDA were investigated. These drugs were found to have some beneficial effects in two or more laboratory assays and were studied further in SOD1 mice. These animal experiments are in progress and Dr Bruijn commented that a report is being written for publication next year.

    Although two of these drugs are licensed for other indications in the UK, it should be stressed that these are very preliminary studies on their possible, beneficial effects for MND.

    13th International Symposium on ALS/MND

    Initial Findings and Concerns Raised
    At the 13th International Symposium on ALS/MND held November 17-19, 2002 in Melbourne, Australia,
    L. Mazzini, MD, and colleagues from Italy reported initial results (6-month) from a pilot clinical trial using stem cells.

    The study presentation raised a number of questions and criticisms of the study design and methods from the researchers and clinicians present. Serious concerns from the scientists in the audience include:
    1. There was no scientific basis offered as rationale to conduct the study.
    2. It is doubtful that the 1.5 milliliters of stem cells were actually injected, as this volume is very large for the space of the spinal cord.
    3. There is not clear evidence that the small change in proximal muscle strength reported can be attributed to an effect of the stem cells. It is not certain that the stem cells actually were delivered into the spinal cord. Other variables, such as the trauma of the injection, could account for the muscle function changes.

    As reported by Mazzini, the aims of this 12-month study-still in process-are to:
    1. Verify the safety and tolerability of injecting autologous mesenchymal stem cells into the spinal cord
    2. Examine the effects of the injection of stem cells, and
    3. Evaluate the impact of the stem cell injection on quality of life

    In this trial of a small number of people with ALS, bone marrow was collected from each patient (autologous) and the mesenchymal stem cells were extracted and later injected into the patient's spinal column. Scientists in the audience raised doubt about whether the stem cells could have actually been injected into the spinal cord as described, given the large volume reported.
    No major adverse events were reported in the first six months of the study. There were minor reports of pain as well as sensory, bladder, bowel and motor problems.

    The study authors indicate that at both the 3-month and 6-month intervals after the stem cell injections, there was a slight improvement in muscle strength that was greater in the proximal muscles than in the distal muscles. Small improvement in neck flexor muscle strength was noted as well. There were a number of questions from attending scientists about whether there was adequate evidence that the muscle changes could be attributed to the stem cells and not from other factors such as the trauma of the procedure itself.

    The investigators will continue the study and report the 12-month end of study findings in a future report. The authors indicate that the stem cell injection was safe and well tolerated, but they cautioned that further studies should be conducted to understand what role the stem cells may be playing. Many clinicians in the audience voiced concerns about safety of injection into the spinal cord and the feasibility and accuracy of this technique. It was noted that the changes in muscle strength could have been a temporary effect of the trauma of the injection or local tissue damage.

    The authors stated that it was not clear why there was a difference in the muscle strength in the proximal muscles versus distal muscles. The potential use of stem cells as future carriers for drugs and other therapies was noted. The possibility that the stem cells are acting as neurotrophic/growth factor agents was discussed. Future trials may include newly diagnosed patients and people with a focal form of ALS.

    In summarizing the Symposium's clinical presentations, Ed Byrne, MD, noted that as the field begins to start considering Phase I clinical trials of stem cells, investigators have to assure that the biological basis and scientific rationale for the potential treatment is sound. He urged that stem cells be tested in the ALS animal models to learn more about the actions and effects the stem cells are actually having.

    Dr. Byrne commented that while there is very little evidence that stem cells can replace motor neurons, it might be possible that stem cells can have an indirect rescuing impact on the motor nerves by altering the environment around the neurons. He encouraged scientists to increase the research focus on how to stimulate stem cells that exist within each person's body (endogenous) to signal the motor nerves damaged by ALS.
    Among the issues to consider before stem cell treatment is ready for ALS clinical trials, Dr. Byrne urged the attendees to address:
    • Selection of the location of the body for transplantation and/or stimulation of the patient's own existing stem cells
    • Technical approach challenges for injection or transplantation
    • Need for clinical protocols
    • Timing - earlier in the disease is probably better
    • Quantification of results with objective tests
    • Immunosuppression to prevent rejection response
    • Need for follow-up care and treatment
    • Long term follow-up or registry of patients who have received stem cells

    Noting that at this time there is little evidence in humans that stem cells provide a benefit in ALS, Dr. Byrne advised that the field should move cautiously.
    I hope that this is helpful.

    Wise.

  7. #17
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    Wise,
    Would you recommend the surgery in China for someone who has ALS? The situation today is she cannot walk or use her legs but has total function of trunk and upperbody. It has been about two years from beginning of symptoms. It is really hard to find any information regarding how well the people who have had the surgery (for ALS) are doing. We've read a few reports of three people who have died from the surgery and one or two people who have gotten worse. My friend is 45 and in good health otherwise. Any advise or information you could provide would be appreciated.
    Linda's friend

  8. #18
    Maaghouse, there is not enough information to say that OEG treatment is effective or not in changing the course of ALS. Although several people have reported subjective improvements in fatigue and strength, not everybody have had similar responses. I don't know the circumstances of the three mortalities but one should bear in mind that many of the 30 or so people who have received the treatment are late-stage ALS and surgery is a risk for people who are not in good health and have significant respiratory compromise. In short, this is not a decision that can be made based on scientific evidence because such evidence is not yet available. Wise.

  9. #19
    This email address does not seem to work. It will be nice if someone can post email addresses of all the doctors who are doing this stem cell or OEC transplant in a consolidated form


    Originally posted by blu stellina:

    Dear Caro,
    this is Dr.Mazzini's mail address in Torino:MazziniI@libero.it.
    Write and she will give you all informations you need.

  10. #20
    Dr. Mazzini's email address is mazzini.l@libero.it Wise.

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