Each year I metaphorically try to look into a crystal ball for stem cell predictions for the coming year and I did so for 2020, but the COVID-19 pandemic threw a monkey wrench into my predictions.
It actually kind of blew some up.
It also raised some interesting questions and dilemmas. For instance, do many kinds of non-cellular research for COVID-19 count as “regenerative medicine”? What about COVID research as regenerative medicine?
Some folks sure seem to think so.
Witness our California state stem cell agency, CIRM (which stands for California Institute for Regenerative Medicine), funding quite a few COVID grants. The FDA is granting RMAT or Regenerative Medicine Advanced Therapy designation to a wide variety of approaches including gene-editing.
You can see my past 2019 predictions along with my grades for them here.
Stay tuned for my 2021 predictions, which hopefully will turn out well.
I give myself a B for 2020, slightly down from my B+ in 2019. Each prediction is listed verbatim as I made it almost exactly a year ago and then my grade for each given prediction follows.
Here are the 20 stem cell predictions for 2020 and my grading of them now on December 30
- 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. Grade: An “A”. It’s been an upbeat year on this front. For example, see this new trial by Masayo Takahashi using organoids that is really exciting.
- 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. Grade: An “A” California Prop 14 narrowly passed as predicted. Here are some of my initial thoughts on the newly refunded CIRM, which I’m calling CIRM 3.0.
- New FDA Commissioner Dr. Stephen Hahn makes some news in the regenerative medicine arena with some surprising action or statement. Grade: An “A”. He frankly screwed up on the convalescent plasma for COVID-19 front, hyping it probably for political, non-medical and non-scientific reasons.
- 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. Grade: An “A” . For example, check out the warning and untitled letters that went out in 2020. We also found out more about that Nebraska situation.
- Looking North, more actions and complications on unproven stem cells and related “regenerative” biologics up in Canada.Grade: C, there has been a little going on but fairly quiet up there. I still see quite a few clinics that seem active in Canada.
- 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. Grade: a “B” as there has been some cool work this year, but less than I thought. Some of the developments were a bit more puzzling too like the one mentioned in this newsy post on a “secret” experiment.
- 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. Grade: An “A” FDA says 55 have been approved even if fewer are in the public domain (see my list of 49 here).
- 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. Grade: An “A” It was a big year for organoids, including notably on the COVID-19 modeling front. Also from Nature, Can lab-grown brains become conscious?
- ViaCyte has an IPO or is acquired or has some other major new good news. Grade: C, no public domain indication of this so far. I still think this is inevitable with just a question of when. The firm did get $27M in more funding, which is good news.
- 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. Grade: “B”. Rebrikov continues to talk this up and apparently do gene-editing on human eggs, but overall there’s been less discussion than I thought, probably due to the pandemic.
- 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. Grade: A “B”. Still some odd things this year, even if to my knowledge no more super bad news.
- 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. Grade: An “A”. This industry remains in hot water as probably one of the sketchiest corners of the regenerative medicine ecosystem.
- 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. Grade: An “A” . Some legit places were unable to place Google ads. Clinics and their promoters have also found workarounds, something I’m hoping to write about in the next couple months.
- 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.Grade: An “A” . Unfortunately several clinics received INDs for COVID work. Politics?
- 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. Grade: C, COVID has brought the courts a near standstill.
- 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? Grade: a “C” as the trial keeps getting postponed by the pandemic.
- 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. Grade: C, relatively quiet except on the RTT for COVID front.
- 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. Grade: An “A”. The agency sent off a stream of letters in 2020.
- 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. Grade: An “A”. Several states stepped up.
- 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. Grade: An “A”. “3-parent” baby born in Ukraine this year and apparently more on the way.