Eight simple reasons not to get an unlicensed stem cell treatment: #3, exclusion from future clinical trials

What’s the big deal about unlicensed stem cell treatments, patients often ask me.

Why should patients avoid these?

Because paradoxically such treatments, intended to cure disease, can have devastating negative consequences for your health.

I’m doing an eight-part series, “Eight simple reasons not to get a stem cell treatment”. The first two blog posts were on the risk to lose one’s insurance coverage for specific treatment-related side effects such as sepsis and the general utter lack of patient follow up by these clinics and doctors.

Today’s post is the third simple reason and that is by getting an unlicensed stem cell treatment patients are almost guaranteeing themselves to be excluded from participation in a clinical trial in the future. By receiving an unlicensed treatment, without realizing it most of the time I believe, patients are in essence putting a big black check mark on any future clinical trial participation pre-screening form excluding themselves. Why? Because by their nature unlicensed stem cell treatments are nebulous and could confound a given patient’s results in a future trial.

This could be disastrous. Let’s take a hypothetical patient who has a back injury and receives an unlicensed stem cell treatment consisting of an injection of stem cells (or more likely multiple injections). A few years later an FDA-approved clinical trial begins for treating back injury using stem cells and this trial seems very promising based on extensive, encouraging pre-clinical animal model data. Our patient would not be able to participate in this trial and as a result may have in essence harmed themselves and been harmed by the doctor doing the unlicensed stem cell therapy by leading to their exclusion from the future clinical trial.

When I’ve had discussions with patients who advocate unlicensed stem cell treatments they say, “who will know?” and “what would simply stop me from lying?”

I suppose this is true, but in that case you are actually harming science, medicine, and possibly other patients because your previous unlicensed treatment may screw up the clinical trial.

Stay tuned for five more simple reasons.

9 thoughts on “Eight simple reasons not to get an unlicensed stem cell treatment: #3, exclusion from future clinical trials


  1. Paul, thanks for this post. It underscores the need for more FDA approved clinical trials. We need more of em and they need to be better designed for sc applications and they need to be promoted. Some patients turn to unapproved alternative options when unable to access an approved clinical trial.
    Thanks for your work, here and in the lab.
    Best Wishes for Happy Holidays,
    Mario


  2. To meet the criteria for a clinical trial for an MS patient is next to impossible! MS is called the “snowflake” disease for good reason. No 2 people are exactly alike. Our symptoms are all so different, that to gather a specific group of MS patients with same disease criteria is tough. 95% of us will NEVER qualify for a clinic trial regardless of prior stem cell therapy! It would just be another reason to exclude with our disease…


    • Hi Jennifer,
      Thank you for the insight. What are the exclusion/inclusion criteria that make this such a problem? Since the disease is diverse, wouldn’t it make sense to make trials more inclusive?


      • Absolutely! That would be wonderful to make trials more inclusive. I think it’s hard to measure the ethicacy of a drug in any MS study (stem cells included) because we all have such different symptoms, while having the same classification or stage of the disease. Many of the FDA approved Interferon drugs are having their long term ethicacy called into question. They drugs are not turning out to do what the initial FDA studies claimed they did. Have any of the ethics professors, or are there any studies, that have looked into what disease community is more likely to seek medical treatment in other countries? I’d be interested to know. It just seems like MS patients are leaving in droves to find AdMSC treatments abroad. I hear a lot about cancer patients doing the same. Another question I have is why is there not outrage over something like the Tysabri clinical trials? There were 60+ patients who literally died, and hundreds who had unacceptable side effects, yet it’s still on the market and fully FDA approved? The FDA fast tracked this drug and gave it a black label! INSANE! One of the current unexpected side effects today from Tysabri, is Herpes Zoster! U just cant make this stuff up!


        • I need to read more about Tysabri. That sounds like a nightmare.
          This dialogue is exactly what I love about blogging–two way communication and I learn so much from you all!


      • As an MS patient I tried to get into the Cleveland Clinic study. I met NONE of the requirements which are: 1) a dx >5 years 2) Optic neuritis 3) Ambulatory. My EF did not meet the requirements of Northwestern….


        • Thanks, Shan, for the comment. I’m sorry to hear about the trials/studies. I’m curious what your thoughts are on stem cell treatments? I myself am extremely skeptical about them just by way of disclosure.


      • I co-faciltate a large online/in person MS support group. We have 100+ members. We frequently invite medical experts to speak. The clinical trial coorinator from a Dallas research university speaks several times a year. To date, not one patient has qualified for a clinical trial. They have stem cell, Estriol and other treatment trials that are ongoing. As Jenny stated, because MS is a “snowflake” disease with an array of symptoms it is difficult to gather a group meeting specific criteria. We have all tried and not qualified for studies. I did offer my lab rat services for a study of electrical nerve stimulation…didn’t treat my MS, was for general study. It proves to be quite difficult as an MS’er to qualify.


        • Hi Tracy, I appreciate your comment and perspectives. I did not realize the extent of the problem with MS trials being so exclusionary.

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