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Thread: China stops unapproved stem cell treatments

  1. #1

    China stops unapproved stem cell treatments

    China stops unapproved stem cell treatments

    By Don Durfee and Sally Huang
    BEIJING | Tue Jan 10, 2012 5:52am EST

    (Reuters) - China has ordered a halt to all unapproved stem cell treatments and clinical trials, state media reported on Tuesday, as Beijing seeks to rein in the largely untested stem cell therapies now on offer across the country.
    The Ministry of Health will stop accepting new applications for stem cell programs, a ban that will last until July and comes as China begins a one-year program to regulate the sector better, Xinhua cited a ministry spokesman as saying.

    A growing number of hospitals and clinics in large cities in China have been offering stem cell therapies for treatment of diseases ranging from cancer and Alzheimer's to spinal cord injuries, treatments that are backed by little or no scientific evidence and which are considered at best experimental.
    Some of these involve large general hospitals where patients pay thousands -- or even tens of thousands -- of dollars for treatments that are advertised online, which attract both Chinese patients and those from overseas, sparking what experts say is a dubious type of medical tourism.

    According to patients, doctors and relatives of patients who spoke to Reuters earlier, patients have come away with little or no improvement and a number have died. Receipts seen by Reuters indicate that one of these hospitals is run by the Chinese army, or Peoples' Liberation Army (PLA).

    The ministry spokesman said health providers could no longer charge money for experimental stem cell applications under the new order, which was jointly issued by China's State Food and Drug Administration (SFDA).
    CAN IT BE ENFORCED?

    Stem cell scientists and experts on medical ethics welcomed the development but they questioned how the health ministry could enforce the new order and reign in powerful arms of the Chinese government, like the army.
    "One thing that is clear about the practice of stem cell medicine in China is that a lot of hospitals are affiliated with government organizations such as the army, the PLA, and the domestic police forces," said Doug Sipp, a researcher into the ethics of stem cell applications at the RIKEN Center for Developmental Biology in Japan.

    Sipp said treatments were normally only introduced after they have proven to be effective in clinical trials and obtained approval from regulatory bodies.
    "I will be curious to see whether this combination of the Ministry of Health and the SFDA is capable of exercising or enforcing the regulations on hospitals which are affiliated with the Chinese government," Sipp told Reuters by telephone.

    Tuesday's announcement is similar to one made in 2009 when China ordered hospitals and clinics offering advanced medical technology to obtain approval or face closure, Sipp said, adding that the order back then did not make much impact.

    The proliferation of unapproved stem cell therapies is not confined to China.
    Experts have raised the alarm about patients turning up at clinics and hospitals in Mexico, India, Turkey, Russia and elsewhere for stem cell therapies that have not undergone clinical trials and are not recognized as standard treatment.

    Last week, the United States' Food and Drug Administration issued a warning about unproven stem cell claims.

    "This is a positive news because there has not been enough regulation, which damaged the reputation of this type of research," said David Siu, a cardiologist and stem cell expert at the University of Hong Kong.
    http://www.reuters.com/article/2012/...8090GA20120110

  2. #2
    This won't affect your trials right? Have the last two been operated on yet?

  3. #3
    Quote Originally Posted by JohnMarz View Post
    This won't affect your trials right? Have the last two been operated on yet?
    I sure would not think so cause it's just cord blood and lithium, if anything it would raise more interest in Dr. Youngs trials I'd think?
    "Life is about how you
    respond to not only the
    challenges you're dealt but
    the challenges you seek...If
    you have no goals, no
    mountains to climb, your
    soul dies".~Liz Fordred

  4. #4
    Quote Originally Posted by JohnMarz View Post
    This won't affect your trials right? Have the last two been operated on yet?
    I think (hope) that it will not affect our current trial. I am more concerned by the statement "The Ministry of Health will stop accepting new applications for stem cell programs, a ban that will last until July and comes as China begins a one-year program to regulate the sector better, Xinhua cited a ministry spokesman as saying." This suggests that the Ministry Health will not accept any new clinical trial application involving stem cells, even legitimate ones.

    The Ministry of Health had implemented such a one-year ban in 2009 and this delayed the onset of our trial for over a year. This follows the pattern they established for controlling organ transplants in 2007, the year preceding the Olympics. To stop trafficking of organ transplants, the Ministry of Health halted "non-approved" organ transplants for a year and required all transplantation centers to become certified before they could do any more organ transplants. Apparently, this was quite effective in controlling organ transplants.

    However, I am not sure that this approach has been so effective for controlling so-called stem cell transplants in China. This is because "stem cell therapies" don't require sophisticated hospital facilities to implement. I have met several people who have travelled into China and paid top dollar to have fetal cells transfused into themselves to "revitalize" their body. Such clinics operate through word-of-mouth and can spring up and disappear within a day. The 2009 ban on stem cell transplants also did not stop organizations such as Beike Biotech although it seemed to have frightened them enough to open an offshore branch in Thailand.

    This time, however, the Ministry of Health seem to mean business this time. The government has a history of being very punitive towards transgressors of highly publicized regulatory changes. A couple of executions and long jail sentences may put fear into those who persist in flouting the law. It is of interest to know how this announcement will affect the olfactory ensheathing glial cell transplants and bone marrow mesenchymal stem cell transplants that are going on in some centers, including several hospitals in Beijing that have been advertising and transplanting such cells for spinal cord injury. As I find out more, I will post.

    Wise.

  5. #5
    I have learned more about the situation. The following is a translation (by Dr. John Chen of ChinaSCINet) of the announcement by the Ministry of Health on 10 January 2012. This statement clarified the situation.

    Announcement of Self-Check and Self-Correction to Stem Cell Clinical Researches and Applications
    MOH, China www.moh.gov.cn 2012-01-06 17:38:53
    Ref No. Sci-Teach-Lttr[2011]1177

    Health Bureaus and Food and Drug Administration (Drug Administration) of Provinces, Autonomous Regions and Municipalities; Health Bureau and Food And Drug Administration of Xinjiang Production And Construction Corps; the Relevant Organizations under the Ministry:

    To promote scientific and orderly development of stem cell therapy and technology, regulate the behavior of stem cell clinical research and application (SCCRA), and normalize the stem cell therapy practices, the Ministry of Health and the State Food and Drug Administration decided to launch a one-year program rectifying SCCRAs. The program will be divided into several stages: self-correction, re-certification, standardized regulation, etc. The works at Self-correction phase are now notified as follows:

    First, the clinical and research institutes engaged in various types of SCCRAs shall, in accordance with the requirements of "Good Clinical Practice" and "the Administration of Clinical Application of Medical Technology", carry out self-check and self-correction for all the SCCRA projects (not including bone marrow transplantation without in vitro manipulation), conscientiously sum up all the finished and ongoing activities of SCCRAs, and accurately report the contents of the investigation.

    Second, to strengthen the organization and leadership, the Ministry of Health and the State Food and Drug Administration have set up an SCCRA Specification and Regulation Lead Group. All the provinces (autonomous regions and municipalities) should set up their corresponding working groups consisting of main leaders of the provincial health authorities and the Food and Drug administrations, to make out their own plans of local self-check and self-correction.

    The provincial health authorities shall seriously clean up all the ongoing SCCRA projects, stopping all the SCCRAs without the approval of the Ministry of Health and the State Food and Drug Administration. Priority will be given to rectify the institutes who, during the self-correction stage, do not accurately report their conditions of SCCRAs, and continue their SCCRA projects without the approval of the Ministry of Health and the State Food and Drug Administration. The SCCRA projects approved by the State Food and Drug Administration should be should be carried out strictly in accordance with Clinical Trial Approval Letter and "Good Clinical Practice" requirements. The protocols must not be changed arbitrarily. The projects can never be charged into paid items without approval.

    Third, new applications will not be accepted until July 1, 2012. Authorities will, based on the existing laws and regulations, actively investigate and propose regulatory draft documents and related technical standards and specifications, and combined with the practical information collected in the self-correction stage, explore and set up the administrative model and long effective mechanism of China regulating SCCRAs. The SCCRA Specification and Regulation Lead Group Office established by the Ministry of Health and the State Food and Drug Administration is responsible for the organization and implementation of specification and regulation works, and the receipt of applications for stem cell clinical researches during this period (from July 1, 2012 to the end of this program). The items aiming to apply for drug approvals should be specified.

    Four, all institutes should take a realistic, serious and responsible attitude, work earnestly to carry out self-correction, filling in "SCCRA self-check questionnaire" (Annex), reporting the problems during SCCRAs, finding out the reasons and suggesting improvements.

    Medical institutions and related research and development organizations shall submit their self-check and self-correction report to provincial-level SCCRA Specification and Regulation Working Group before January 31, 2012. Provincial SCCRA Specification and Regulation Working Groups shall summarize the relevant self-correction works of local medical institutions and research organizations, and report before March 1, 2012 to the SCCRA Specification and Regulation Lead Group office of MOH and SFDA.

    The works related to the medical institutions belonging to the army and armed police forces will be conducted by the Army MOH and the General Logistics Department of the Armed Forces referring to the requirements of this announcement.
    This announcement was accompanied by a form which required all facilities carrying out stem cell clinical research and application (SCCRA) to submit descriptions of ongoing projects, specifying the approval status, approving organization, and approval number, the source of cells, the number and status of patients, etc. From this, the following is clear:

    1. The Ministry of Health (MoH) is requiring all provincial and other health organizations to collect information about SCCRA, to ensure that the projects follow good clinical practice (GCP) guidelines and approved protocols, and to shut down projects that are running without proper approval.

    2. All the information must be submitted before January 31, 2012. The information will be summarized and provided to a SCCRA Specification and Regulation Working Group by March 1, 2012. Work being conducted by military organizations will be reviewed by the Military MoH and General Logistics Department of the Armed Forces.

    3. The MoH will not accept any new applications for clinical trials until July 1, 2012. During the self-correction period, the organizations shall "seriously clean up all the ongoing SCCRA projects" and must take a "realistic, serious and responsible attitude, and work to earnestly carry out self-correction", reporting problems, finding out reasons, and suggesting improvements.

    So, the MoH is making a serious effort to eliminate all non-approved cell transplant activities in China. To facilitate this cleanup, no new clinical trial applications will be accepted before July 1, 2012. The language seems quite strong and leaves few or no loopholes. Any SCCRA project must be either be approved or shut down. It may not stop some fly-by-night clinics that are operating without approval but no legitimate hospital or medical clinic in China would take a risk of doing cell transplants without approval. The announcement goes out of its way to say that hospitals cannot charge for the cell transplants.

    Regarding the effect of this announcement on ChinaSCINet, I think that it will have little effect on our current trial, which is approved by the Military MoH and supported the Yunnan Department of Science and Technology. It may slow us down in terms of any clinical trial application between now and July 1, 2012 but we currently have no plans to do so.

    Wise.

  6. #6
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    I hope this will not be hurdle for starting trial on lumbosacral injuries next year hopefully Wise.

  7. #7
    He just explained all of that

  8. #8
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    Ok Colin. Best of luck for Wise. He is very very hard efforting person

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