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Stem Cell Educator Starts Two Phase-II Trials

Discussion in 'Research' started by joshualevy, Apr 14, 2018.

  1. joshualevy

    joshualevy Approved members

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    The Stem Cell Educator (SCE) is an attempt to cure established type-1 diabetes by exposing a patient's immune cells to umbilical stem cells, and then returning the cells back to the patient. Each person had a blood draw, and then a particular kind of immune cell was separated from the blood and specially processed. The processing phase uses umbilical cord stem cells previously donated by a third party. The patient's own "educated" immune cells were then returned to the patient. The stem cells did not go into the person; they were only used for the external processing.

    In the last six months, two new studies have started, which I blog on below. The first is in New Jersey and the second Beijing.

    The New Jersey Clinical Trial (NCT02624804)

    This study will enroll 10 people. Everyone will be treated (no control group, no blinding).

    The end points are mostly safety related, but there will be some efficiency related end points as well. There is no mention of collecting efficiency data (such as C-peptide numbers, A1c data, blood glucose, insulin usage, etc.)

    This study has started recruiting. There was hope it would start in mid 2017, but the study needed some lab infrastructure which the medical center did not have at that time, hence the delay while the new labs were set up.

    Recruiting at one site: Hackensack University Medical Center
    Hackensack, New Jersey, United States, 07601
    Contact: Mariefel Vendivil 551-996-5828 Mariefel.Vendivil@HackensackMeridian.org
    Contact: Andrea Ortega 551-996-3923 Andre.Ortega@HackensackMeridian.org

    Clinical Trial Records: https://clinicaltrials.gov/ct2/show/NCT02624804

    But note that this clinical trial record is out of date. The study has not yet started recruiting, no efficiency end points are listed, and the completion dates are too short.

    The Beijing Clinical Trial (NCT03390231)

    This study will enroll 100 people. Everyone will be treated (no control group, no blinding).

    The primary end point will measure specific immune cells (which are involved in type-1 diabetes) one month after treatment. Secondary end points will cover insulin sensitivity after a month, and A1c, blood glucose, and c-peptide measurements after three months.

    They started in Nov-2017, and hope to finish in either July-2018 or Dec-2020 (see discussion below).

    Recruiting at one site: Department of Endocrinology, Chinese PLA General Hospital
    Beijing, China, 100853
    Contact: Yu Cheng, MD,PhD 86 10 55499301 chengyu_301@163.com
    Contact: Yiming Mu, MD,PhD 86 10 55499301 muyiming@301hospital.com.cn

    Clinical Trial Records: https://clinicaltrials.gov/ct2/show/NCT03390231

    Discussion

    Differing Results: This treatment has been previously tested twice before. One of these clinical trials had strong results, but the other one had very weak results. I've blogged on these in the past:
    http://cureresearch4type1diabetes.blogspot.com/search/label/Stem Cell Educator
    The researchers believe they understand why the two trials had different results, and are hoping to apply this knowledge to the current two trials, in order to get better results.

    Date confusion: The FDA's clinical trial registration page requires researchers to list three dates for a clinical trial: start date, primary completion, and study completion. (Once the trial starts, the first is known, while the second two are estimated.) The primary completion date is when the last data for the primary outcome will be gathered. The study completion date is when the last data for the study will be gathered.

    For the Beijing study, the primary completion date is May-2018 and the study completion date is Dec-2020. However, the primary end point is a month after treatment, while the secondary end points are either one or three months after treatment. So that means the study completion date should be two months after the primary completion date, not 2 1/2 years! My guess is that there are some two year end points as well, which are not listed in the clinical trial registry. (The New Jersey trial also has two year end points which are not listed in the registry database.)

    Joshua Levy
    http://cureresearch4type1diabetes.blogspot.com
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
     
  2. rhill

    rhill Approved members

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    Joshua, thank you for posting this. I read about this Stem Cell Educator therapy last year and thought it was only beneficial for patients in the honeymoon period. I was surprised to read that this may help established diabetics as well. That's great news.

    Wouldn't this mean that any therapy that stops the autoimmune attack would potentially be a cure? For example, the Sanford T-Rex method also stops the autoimmune attack. So wouldn't that also allow the beta cells to regenerate and lead to a cure?
     
  3. joshualevy

    joshualevy Approved members

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    Maybe, but not necessarily. There are two was of looking at this: the "general" way and the "specific" way.

    Generally, one of the fundamental questions of type-1 diabetes is exactly the question you ask: "if we stop the autoimmune attack, will the beta cells naturally regenerate (without further intervention)". Ten years ago (and prior) the consensus was that beta cells did not regenerate very much, and this was unlikely to work. However, more recently evidence has accumulated to suggest that maybe beta cells do regenerate fast enough to lead to a cure. For example, pregnant women generate enough extra beta cell mass to generate insulin for a fetus during pregnancy. Unfortunately, unless we develop a treatment which ends the autoimmune attack, it is very hard to test to see how quickly beta cells would regenerate. I think the current scientific consensus is (still) that they would not regenerate fast enough, but that consensus is not nearly as strong as it once was. However, if they do regenerate fast enough, then any autoimmune cure will end up curing type-1 because the beta cells will take care of themselves. Any honeymoon cure will become a cure for established type-1. This would be great.

    Specifically, the researchers working on this cure think that it may effect both the autoimmune attack and regrowing beta cells. If that turns out to be correct, then this particular cure will be a complete cure for both honeymoon and established type-1 diabetes, and this would be true even if the more general beta cell regrowth theorey turns out to be wrong.

    Bottom line: if this does turn out to be a complete cure, then maybe all honeymoon cures would turn out to be complete, but maybe not. However, it won't really matter (to me at least) because it is the first cure that I really care about.

    Joshua Levy
     

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