In any given field of biomedical science like stem cell research and regenerative medicine, it’s very useful if you can accurately predict the future.
It seems, though, that predictions are far more difficult within the more exciting and rapidly-changing fields.
The field of stem cells and regenerative medicine fits that bill.
Past stem cell research predictions
Still, each year in late December or early January I’ve made predictions for the coming year for stem cell research and regenerative medicine. More often than not I do reasonably well with these predictions.
Of course, no one can in advance factor in for an unexpected pandemic like in 2020.
It’s fun for me looking back over these older predictions and readers enjoy it as well.
For example, way back in 2010, I was trying to predict what would happen with IPS cells and asked readers to join in that effort.
Then for 2011 I did my first predictions of a more formal, general sort.
It’s interesting to see the emphasis back then in 2011 on ES cells and also some discussion of IPS cells vs. transdifferentiation (direct reprogramming).
Each year I also grade my predictions at the end of that year, which can be a sobering experience.
Which of my predictions are most likely to be right and which ones wrong?
I front-loaded some of the expected good news.
Here are my predictions for 2021
- More good news on gene-editing for Sickle Cell/Thalassemia front. Things continue to look encouraging with the ongoing clinical trial and there are other trials as well that bring more hope.
- CRISPR Therapeutics has a very good year. Related to the prediction above and additional work in the pipeline, this biotech has a positive 2021.
- Stem cell & regenerative medicine biotech blues, maybe with a few exceptions. Unfortunately, overall, half or more of the top 10 or so biotech firms in the stem cell sector will have a net decrease in YTD share price at the end of 2021. I hope there are some notable exceptions to this of firms that do extremely well in the broader regenerative medicine space like CRISPR Therapeutics and other more focused cell medicine firms.
- Good news on the HSCT for MS and other autoimmune diseases front. While the prominent Burt-Northwestern HSCT program has remained shut down, other research on using hematopoietic stem cell transplantation for multiple sclerosis and other autoimmune diseases will continue looking very promising.
- The cell medicine for COVID-19 front doesn’t produce an FDA-approved treatment. It’s been an unpopular view, but I’ve never been very enthusiastic about the idea of stem cells for COVID-19. While the University of Miami 24-person trial enthusiastically reported some apparent effects a few days ago, there are quite a few caveats there so we need to see how a subsequent larger study goes by them as well as outcomes of dozens of other trials using cells for the novel coronavirus disease. I predict no fully FDA-approved cell therapy for COVID during 2021 and mostly discouraging results for the trials in this area overall.
- But COVID cellular medicine continues as a hot area. Despite the first prediction above, we’ll continue to see new trials, probably new INDs, and a whole lot of exuberance about the idea of cellular medicines as a treatment for COVID-19, even from ISSCR. I hope I’m wrong with my skepticism on this.
- More CIRM clinical trials. CIRM funds at least 6 more new clinical trials in 2021. The new funding from Prop 14 California is a big boost, of course. CIRM also looks to be stepping up funding of more basic/translational research somewhat as well.
- An encouraging year for regenerative medicine related to vision loss. We see more concrete steps forward for stem cells and other cellular medicine approaches to vision loss including macular degeneration.
- DIY human CRISPR will be back in the news. As the pandemic hopefully fades at least somewhat, we’ll see more attention given to CRISPR uses in people that defy norms. Hopefully not more CRISPR babies, but who knows.
- State AG lawsuits vs. stem cell clinics expand. Good news as state-level efforts to reign in stem cell clinics continue and expand by at least 1 and probably 2 or more states taking concrete actions like lawsuits.
- FDA still strongly engaged on unproven clinics. More good news as the FDA will start ramping up more actual warning (not just untitled) letters to unproven stem cell and regenerative clinics, including at least 3 new warning letters and probably more. There will be more untitled letters too.
- Hahn is out and the new FDA Commissioner will not be Robert Califf, Scott Gottlieb, or David Kessler. Ned Sharpless and current CBER Director, Peter Marks, would be excellent. They would be somewhat unexpected picks because they are not politician-type people. Peggy Hamburg, past Commissioner under Obama-Biden, could be selected again. Another name being floated is current Principal Deputy Commissioner of Food and Drugs, Amy P. Abernethy, MD, PhD, who could be selected. As of January 12, Biden still does not have a pick announced as of the writing of this post, which could signal an unconventional pick or just that they are busy with other stuff.
- Post-pandemic stem cell clinic marketing. Some unproven suppliers and operations selling stem cell and regenerative offerings try to make up for lost profits by being even more egregious in their marketing and hype. It is also possible on the more positive side that some clinics will not recover as businesses to be active post-pandemic.
- Production of gametes from stem cells in the news. More developments on making human eggs/sperm from stem cells. While this gives hope for possible future fertility treatments, it also raises some thorny ethical/societal issues.
- Exosome troubles. More iffy exosome situations in 2021. This problem is not going away.
- No luck for stem cell clinic US Stem Cell in its appeal. This clinic firm will be unsuccessful in its court appeal of the permanent injunction against it or the appeal will still be pending due to the pandemic before years end, leaving the injunction in place.
- As to the other federal fat stem cell case, I predict by year’s end it’ll be FDA 1, Cell Surgical Network 0. I expect that this stem cell clinic chain will lose in federal district court and then they will appeal the ruling. The appeal could take a long time. If I’m wrong about this prediction and CSN prevails, then the area of FDA regulation of cellular medicine and in particular of fat stem cells could get shaken up. It’s also possible the case could remain unresolved due to the pandemic.
- Japan has stem cell ups and downs. Stem cell clinical trials continue to build in Japan which is great, but the country also faces challenges on the regulatory front including from for-profit clinics. I also expect we’ll see more such up and down developments from Australia and Italy too.
- Young blood. This idea of using young people’s blood to help stem aging in older folks just won’t go away in 2021 and/or the FDA/FTC will have to take some major additional action in this area.
- PRP stays hot. Stem cell clinics and universities/large medical centers continue to market platelet rich plasma or PRP for a variety of conditions. Does the evidence back it up? We’ll see if there’s more data in 2021, but so far I’d say the evidence for most applications is not clear-cut. Some stem cell clinics will switch to mainly PRP as the regulatory window to use fat stem cells or SVF closes per the FDA enforcement period.
- Perinatal products. Unfortunately, selling and using iffy birth-related “stem cell” products will continue to be hot (including via chiropractors) and spark more FDA action. Note that these products often are just useless, dead cellular debris.
Some other areas are likely to make news such as umbilical cord stem cells, probably futile stem cells for autism research & stem cell clinic offerings, stem cells/regenerative medicine use by athletes and politicians, and more.
What are your predictions for the new year of 2021 for our field?
Share yours in the comments or give your reactions to my predictions.