2023 stem cell predictions grades reflect wild year for regenerative medicine

Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall.

Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you can see the full text of each prediction and some context I might have given in the 2023 prediction post.

Here’s a list of past predictions with my grades of how they did: 2022, 2021, 2020, 2019, 2018, 2017, 2016,2015, 2014, 2013, 2012, and 2011.

Stay tuned for my 2024 predictions.

Let’s dig into what happened this year. This post is also kind of a year in review.

stem cell predictions
Stem cell & regenerative medicine predictions for 2023.

FDA & stem cell clinic predictions and grades

1. The FDA wins its unproven stem cell clinic appeal of the verdict in the Cell Surgical Network lawsuit. Grade: TBD. My error here in this prediction was thinking there’d be a court decision before 2024.

2. Anemic clinic oversight continues at the agency overall. Where the FDA will be most active in 2023 is in the perinatal space. Grade: Correct. The FDA continues to disappoint on stem cell clinics overall. Not enough bandwidth? Lack of will to tackle this huge mess? At least they continued their relatively higher activity in the perinatal space.

3. Unproven exosomes. Unproven exosomes make more big news. Regenerative clinics and suppliers will continue to sell iffy exosomes. Will the FDA do more on exosomes? Who knows? Grade: Correct. The exosome marketing continues and the FDA hasn’t been able to effectively address it so far. It is on their radar screen at least.

4. ExoFlo, et al. Speaking of exosomes, there will be some development on the firm Direct Biologics and its ExoFlo product. Another exosome drug manufacturer, Kimera Labs, could make news too. Grade: Correct on both accounts. A new ExoFlo clinical trial pub appeared but wasn’t very convincing to me. Kimera Labs finally got their long-awaited IND for their exosome product for COVID.

Embryos and stem cell models

5. Crossing the line with human embryos. Someone grows human embryos past the previous 14-day rule limit. This could be Jacob Hanna and his firm Renewal BioGrade: TBD. Nothing in the public domain that I saw on actual embryos but I think it could have happened already.

mouse embryos grown in the lab, embryo engineering, ISSCR
Mouse embryos grown in the lab in vials. A. Aguilera-Castrejon et al., Nature 2021.

6. Embryo models. Stem cell-derived human embryo model research continues to be hot. Grade: Correct. There’s already been a lot of drama. A conflict between Hanna and Zernicka-Goetz made international news. The new papers on embryo models in 2023 have been quite interesting.

Jacob Hanna Renewal Bio
Jacob Hanna, Founder of Renewal Bio, talking about embryo models in a TV interview.

CRISPR & gene therapy

7. CAR-T continues good news.  Grade: Correct. CAR-T is one of the most exciting areas of combined cell and gene therapy. One cautionary development was the presence of new T-cell malignancies very rarely in those receiving some CAR-T.

8. More good news here as the gene-editing clinical work on sickle cell disease continues to be promising. Grade: Correct. RNA-based therapy for sickle cell, Casgevy, got UK approval for sickle cell. Both Casgevy and Lyfgenia were approved in the U.S.

He Jiankui
He Jiankui is back doing genetic research and will make more news in 2023. Photo from He Jiankui.

9. He Jiankui in the news. Will He Jiankui stay out of trouble? Grade: Correct. He proposed editing embryos again. 

10. Is someone else going germline?. Grade: Incorrect as far as I know.

11. Cell and/or gene therapy safety concern. Grade: Correct. Several firms have reported issues but side effects still remain relatively rare fortunately. For example, Astellas trial participants had some issues and clonal selection was reported in a short hairpin RNA trial. This year it was reported that CAR-T therapies also may very rarely cause new T-cell malignancies. 


12. Another rough year for most regenerative biotechs. Most likely 2023 will be another bad year for Athersys, Mesoblast, and BrainStorm Therapeutics. Grade: Correct. Only a few stem cell stocks did reasonably well. I highlighted 3 biotechs that were doing well recently. You can see the 24 stem cell stocks that I follow. 

13. More RMATs. The number of FDA RMATs goes up at least 10% more. It’s hard to tell so far if anything has come of all these RMATs. Too early to say? What do you think?Grade: Correct. There were 71 RMATs as of 2022 and now there are 85 on my RMAT list. The FDA says there are even more but they aren’t in the public domain it seems.

14. Vertex/diabetes. Vertex has made big headlines and gotten some very favorable diabetes-related coverage including from the NYT.  Leaning positive, I think we’ll hear some concrete plans and news from Vertex in this space in 2023 related to diabetes clinical trial work. More broadly, Vertex seems like a strong biotech with a proven track record. Grade: Correct. Things still look encouraging. Overall, Vertex had a very good year too.

15. Cord blood banking/therapy downturn continues. Firms like Cryo-Cell and ViaCord don’t have a good 2023.  Grade: Mostly incorrect. Cryo-Cell ended the year modestly higher as a stock. I still am skeptical that they will ever open their therapy clinic via their big-money deal with Duke. ViaCord is part of Revvity (RVTY), which had a bad year.

16. The idea of stem cells or other cells for COVID still mostly languishes. Grade: Correct. Still no clear data this is a valuable avenue in my opinion.

More predictions

17. Organoids. More interesting developments on organoids. Grade: Correct. We also saw more attention to assembloids.

brain organoids eyes
Brain organoids with primitive eye-like structures.

18. De-extinction is hairy even in the planning stages. The efforts to bring back woolly mammoths generate more tough questions. Grade: Correct. The team keeps “watering down” the creature that they would make to the point that, even if they were ever successful, I wouldn’t call the organism a mammoth anymore. It’d maybe be more elephant than mammoth, have no tusks, etc.

19. Human cloning is in the news. Grade: Mixed bag. I have heard of some researchers still floating the idea. Netflix dropped a new documentary show on Hwang Woo-suk, who faked human cellular cloning. He now clones pets. Netflix also gave us a documentary on Macchiarini. Can they do a documentary series on some good news in the regenerative arena?

human cloning
Human cloning will be in the news in 2023. This is an artistic representation of cloning by Daisuke Takakura.

Changes and setbacks

20. Tessier-Lavigne is no longer Stanford President by the end of 2023. Grade: Correct.

21. Mixed news on iPSC trials in Japan. Grade: Correct. There has been a mixed-bag of news coverage on iPSCs in Japan and what the future might hold. For example, see this editorial on iPSCs.

22. Elon Musk’s Neuralink has its brain frozen.  Grade: Mostly right. There was bad news as the effort to get a trial was frozen for a time but now it appears to be proceeding. The company still faces many challenges including more bad news of a recent call for Musk to be investigated for fraud regarding statements on Neuralink.

23. FDA leadership change. A major leader at the agency leaves. Grade: Incorrect. Maybe it’ll be in 2024.

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