20/20 vision? The Niche’s 20 stem cell & regenerative medicine predictions for 2020

The Niche stem cell predictions 2020Every year in December and early January I do a post predicting some key events for the stem cell and regenerative medicine field for the upcoming year and today’s post contains my predictions for 2020.

You can see my past 2019 predictions along with my grades for them here.

I gave myself a B+ for 2019.

What grade will I get for 2020? I don’t yet of course, but I often can’t resist making positive predictions even if they are relatively high risk in the sense of maybe not coming true within a year. We’ll see.

What stands out for 2020 in my view?

Some surprises are coming from the FDA I think in the next 12 months. The stem cell clinic industry including in particular birth-related and fat stem cells is going to have a really bad year, which is good news for patients and the legitimate stem cell and regenerative medicine field.

Here are the 20 predictions for 2020.

  1. 2020 is a good year for pluripotent stem cell-based vision clinical research. More encouraging developments for pluripotent-stem cell based clinical trial efforts related to vision loss. However, most likely also another setback from a specific study in this area.
  2. CIRM’s future funding narrowly gets funded by California voters. The vote on a new round of funding for CIRM passes, but probably by a narrower margin than the original CIRM Proposition 71. Great news for the stem cell field. Here is the text of the new initiative. 
  3. New FDA Commissioner Dr. Stephen Hahn makes some news in the regenerative medicine arena with some surprising action or statement.
  4. Sketchy exosome troubles mushroom. More problems from unproven exosomes. See this post with a bit of info on as-yet not well-defined problems in Nebraska in 2019 from sketchy exosomes that sickened patients. I hope to have more details on what happened in Nebraska in the next few weeks. The FDA may caution an exosome producer in 2020. I hope so! For more on what exosomes are and legit research in this area see here.
  5. Looking North, more actions and complications on unproven stem cells and related “regenerative” biologics up in Canada.
  6. Good news on Parkinson’s. More promising developments on the stem cells for Parkinson’s Disease front. Work across the world on this front is exciting including here in the U.S., Japan, and other countries.
  7. RMATs continue to quickly trend up in number. The total number of FDA granted RMATs gets to 50 or more by the end of 2020. For a running total of these regenerative medicine advanced therapy designations granted see here. At the same time it’s probably going to be clearer that a few firms may be getting RMATs mostly for PR reasons.
  8. Organoids continue to make headlines and in particular human brain organoids spark both exuberant and more nuanced media coverage. The electrical (“brain wave”) activity area is going to continue to draw attention and probably more pubs.
  9. ViaCyte has an IPO or is acquired or has some other major new good news.
  10. CRISPR babies stay in the headlines as fallout from He Jiankui’s (and two others’) prison sentences reverberates, but even so at least one other scientist still talks up making human babies with heritable modifications.
  11. Liveyon gets even more bad news. Liveyon is a troubled supplier of perinatal products that ran into a lot of problems in 2019 including patients ending up hospitalized after getting their product. They voluntarily suspended sales of their products late in 2019 after getting a warning letter. Will the firm “live on” as a supplier of non-FDA-approved stem cell offerings in the U.S.? There’s a good chance a substantial portion of the firm’s operations will be outside the US by early 2021.
  12. Perinatal stem cell clinic industry gets hammered. The unproven perinatal stem cell arena (including umbilical cord, amniotic, and/or placental products) more broadly takes more hits including from the FDA and maybe state AGs or other governmental bodies. These biologics are generally being sold despite being unapproved drug products.
  13. Google’s ban on stem cell clinic ads runs into some issues, in part because of the search giant inadvertently also limiting ads for legit institutions that just happen to do some FDA-approved stem cell clinical trial work. For more on the ban see here.
  14. One or more stem cell clinics or suppliers announce going for an IND or IDE via the FDA. Less likely but also possible is that FDA clears such an IND or IDE. Things are complicated in our ecosystem so this one may catch a lot of people by surprise.
  15. More bad news for clinic firm US Stem Cell possibly on their appeal of their loss in federal district court or more broadly as a publicly-traded company. There’s also likely to be some concerning or puzzling news about the firm’s cryobank of customer stem cells.
  16. Cell Surgical Network, a group of clinics marketing SVF (“fat stem cells”), loses to the FDA in the case for a permanent injunction in California federal district court. An appeal is almost certain. Could they go against my prediction (I’m not an attorney) and win the case? Any attorneys out there in how that might be possible?
  17. Right-To-Try specifically in the stem cell sphere leads to more controversy and maybe patient harms. See more here about what went on in this space in 2019, which was concerning, and my 2019 interview with Richard Garr who is a RTT proponent.  It’s not clear that RTT using stem cells will benefit patients and I believe it is more likely to have negative repercussions.
  18. The FDA takes 4 or more big actions such as warning letters and/or lawsuits seeking injunctions via DOJ. When the 3-year grace period for clinics to come into compliance ends in November, a lot could happen nearly at once.
  19. More state level developments on stem cell/regenerative clinic firms. Two or more states make news against stem cell clinics or suppliers including potentially having legislation related to unproven stem cell & regenerative medicine offerings and/or AG actions. I wish I could say with certainty here in California that we’ll see some concrete action against unproven stem cell firms, but things are moving slowly despite a recent state medical board task force meeting I attended.
  20. So-called “3-parent” babies or “mitochondrial transfer” babies back in the news. One possibility is that fertility doc Dr. John Zhang (张进医生) of New Hope fertility Clinic in New York pops back up more. Zhang made headlines in past years for making an unauthorized 3-person baby and reportedly had met in 2019 with He Jiankui about business ideas. It’s also possible that the efforts in this area in the UK reports a development. It’s also apparently going on in Ukraine.

4 thoughts on “20/20 vision? The Niche’s 20 stem cell & regenerative medicine predictions for 2020”

  1. 2 of Liveyon’s products were pulled by Liveyon as they are ready for submission to FDA for IND consideration. Now they are classified as 351s and cannot be distributed domestically as 361s
    This is good news! Please don’t cast an unwarranted cloud over them.

    1. @Lexi,
      Actually, the FDA warning letter and the firm’s own statements about the living allogeneic cellular nature of the products suggest to me that their umbilical cord products were most likely 351 all along. So I’m not sure why you are using the word “now”. Companies surely don’t get to unilaterally decide whether their products are 361 or 351.

      Did you read the FDA warning letter? It raises so many concerns.

      It’ll be interesting to see how committed this firm is to getting FDA-cleared INDs and BLAs over coming years of hard work even as they aren’t making profits on these products. Also, will they hire or already have on staff rigorous scientists and FDA compliance experts?

      You can’t just wing this kind of stuff.

      Meanwhile, I wonder if the FDA will take action on the other perinatal suppliers that seem to me to be selling unapproved drug products still.

  2. How could stem cell leader Athersys be missing from the list? With ards P 1/2 365 day data pending and 2 clinical trials to finish enrolling patients in Japan this year, I think you may have overlooked this one. I also believe we will see another partner this year.
    We shall see…….

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