Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024.
You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please check that out below and subscribe to our channel.
We’ll start with 2024 predictions about what arguably was the most hyped part of our research area in 2023. Anti-aging or longevity. And, no, we’re not all going to be living to 120 in the coming decades. Even so, it’s an interesting area with some notable characters that will make news in 2024.
Anti-aging: longevity arena headlines
1. The press continues to eat up what Bryan Johnson, David Sinclair, and others say and do in their high-profile anti-aging efforts. The 2023 The Screamers Science Hype Award went to coverage of this kind of stuff.
2. There is some controversy or someone gets hurt related to unproven longevity efforts. This could be due to any number of what I see as high-risk longevity approaches. Maybe gene therapy or unproven stem cells? Perhaps, some other unproven biological approach. I wrote recently about how extreme anti-aging efforts could be harmful or even fatal. The longevity space also continues to emphasize over-testing such as too frequent whole body scans and MRIs. In this area, in my view, some players seem to be advocating levels of testing, that while likely very profitable, may not do customers a whole lot of good overall. What about Fountain Life?
3. Altos Labs. More news, probably largely upbeat, from the relatively new and unconventional biotech Altos Labs. They are pursuing cellular rejuvenation to improve health and perhaps extend life using rigorous approaches. I did a quick analysis of recent research papers from Altos Labs and found a heavy emphasis on human aging and DNA methylation.
Gene editing & gene therapy ups & downs
4. More encouraging news on gene editing and gene therapy clinical trials in 2024. These upbeat developments build on the approval of Casgevy in the UK along with both Casgevy and Lyfgenia in the US by the FDA for sickle cell disease.
5. More adverse outcomes from gene editing & gene therapy trials. We saw several reports of health problems for participants in investigational gene therapies in 2023. As the number of such trials and participants continues to increase in 2024, it’s only natural to expect more adverse events. It doesn’t mean there’s anything wrong with these overall overlapping clinical approaches. We should take evidence of adverse events seriously but keep in mind that some risks will come with these new approaches. One recent death in this gene therapy space was likely due to the vector used.
Biotech predictions
6. Another rough year overall for cell therapy and regenerative biotechs. Many stem cell biotech firms continue to struggle in 2024. Most of the 24 stem cell stocks that I’m following do not have a positive 2024. Some firms like Mesoblast, Athersys, Pluristem (now going by Pluri, Inc.), BrainStorm Cell Therapeutics, and Celularity were so far down in 2023 that one might see potential for one or more bouncing back in a big way in 2024. I hope that happens but it’s hard to say which one might have the most upside.
7. Some stem cell and regenerative biotechs break the trend and do well. I predict that Vertex, CRISPR Therapeutics, and Regeneron, which were 3 biotechs that I highlighted in 2023 as doing well, will have another positive year in 2024. Note that I’m not a biotech investor and this is not financial advice. Avita Medical RCEL is a new one on my radar screen thanks to a The Niche reader. It had a great 2023 and has some solid but very cool technologies. What do you think it’ll do in 2024?
8. Elon Musk’s Neuralink has more troubles. Neuralink somehow got an IND to start a trial of its brain implant in humans. This was after the FDA had frozen the program due to many problems. It seems likely to me that the firm will have more problems in 2024, which I expect will be another roller coaster year for the firm.
FDA oversight of stem cells
9. FDA prevails in its appeal of the Judge Bernal verdict in the Cell Surgical Network lawsuit. This case centers on whether certain adipose cell preparations are a drug or not. I think Judge Bernal got it wrong and hope the appeals court focuses on the science.
10. The FDA moderately increases actions on unproven stem cell clinics overall in 2024. This uptick goes beyond just the perinatal space, where it was relatively more active in 2020-2023. I’m being an optimist on this one as for many years the agency has failed to do enough about these clinics.
11. Still a lot of marketing of non-FDA-approved exosomes/extracellular vesicles (EVs). The sad thing here is that exosomes and EVs more generally have real potential. Clinics and suppliers are latching onto the potential profit margin though now. On the flip side, we may see more cleared INDs, which could be good news.
12. ExoFlo and Kimera Labs in the news. Direct Biologics and its ExoFlo product will make more news in 2024. I expect some kind of substantial news on Kimera Labs too, which could be related to FDA oversight.
Embryos and stem cell model predictions
13. Crossing the 14-day rule with human embryos. This was one of my seemingly incorrect predictions from 2023 but I’m sticking with it for 2024. Someone will grow human embryos beyond 14 days. While this is not permissible in some countries, in others rules don’t exist or are vague. A researcher may have crossed the line in 2023 but that info is just not yet in the public domain.
14. Embryo models. These stem cell-based human embryo models continue to draw attention with more high-profile papers and perhaps additional news. I see them as powerful tools but they need to be used judiciously in research. One of my concerns is how we would know if an embryo model is so good that it crosses the line to be functionally a real human embryo.
Vision research
We’re going to see both ups and downs in the regenerative eye space.
15. More encouraging clinical trial data on stem cells for vision issues and eye health. On the positive side, at least one and probably more clinical trials will report positive results on using stem cells or other regenerative approaches to eye issues. The massive problem of macular degeneration needs novel approaches.
16. Biological eye drop problems. On the other hand, there will be more news on negatives related to biologics-based eyedrops. Already in 2023, we saw the FDA warning about amniotic fluid eye drops. For example, Regener-Eyes got warned.
17. We’ll hear more about people who lost their vision going to unproven stem cell clinics.
Neurological conditions
18. Some encouraging news on the stem cells for Parkinson’s disease front.
19. More reports on the interesting question of stem cells in the brains of adult humans. I believe there are stem cells in the adult human brain but some scientists are skeptical.
20. Stem cells for stroke and/or Alzheimer’s (or both) make big news again in 2024. In past years some folks both in the stem cell clinic sphere and in academia claimed miraculous results in this area, particularly for stroke, but the data were always pretty minimal.
From the clinical protocols using pigmentary epithelial cells, derived from iPS or ESC, is there any positive results in macular degeneration?
Paul ,
Break out year for LCTX Lineage Cell Therapeutics and Genentech ‘s clinical trials on OpeRegen with their phase II results this late spring or early summer on #1 unmet medical and dry AMD treated with RPE transplanted cells in 60 patients ……One other stem cell point will Mesobalst get FDA approval on their G vs HD using Mesenchymal stem cells this summer ?
I think there is real potential there too with LCTX.
I wish I had a clearer idea on Mesoblast and FDA. It definitely is interesting to compare Mesoblast approval elsewhere vs. what’s happening with the FDA here in the US.
Do you know new results of using beta cells, derived from embryonic stem cells, included in microchip and placed subcutaneously in patients,?