Toward the end of each year I make predictions for the stem cell and regenerative medicine field for the coming year. I’ve been doing this for more than a dozen years in various forms.
In this post I’m looking at the (gene-edited, stemness enriched) tea leaves for 2025 for the regenerative arena. These predictions include gene editing and gene therapy research. You can check out my stem cell predictions for 2024, which I will grade soon. It’s looking like the 2024 predictions were solid.
Looking ahead, I’ve divided the 2025 predictions into groups by topics However, one overall prediction is that the FDA is going to be facing a tough 2025.
2025 regenerative medicine and stem cell predictions
FDA under year one of Trump 2.0
- 1. Less FDA oversight activity. The FDA has been far more active in 2024 than the average of the past five years on stem cell clinics, manufacturers, and other firms involved with unapproved regenerative drugs. In fact, 2024 was probably a record year for FDA warning letters on biologics. With the new administration, this is unlikely to continue past the first few months of 2025. More activity overall seems relatively unlikely given the potential role of RFK Jr. and his views on stem cells. If RFK does not become HHS secretary then it may not be so bad.
- 2. If he’s confirmed as HHS Secretary, I predict that RFK Jr. and Trump will have a breakup before the end of 2025. I see these guys as ultimately incompatible.
- 3. At least one and maybe more key FDA approvals of a regenerative medicine product, probably Mesoblast. We’ll see another major European and probably FDA approval in the regenerative space. There’s a better than 50% chance of some long-awaited good news for Mesoblast. It could even be for Capricor or a gene therapy. Or both or some other approval. I expect Marty Makary to be confirmed as FDA Commissioner and to catalyze more approvals in our arena in coming years including probably 2025.
- 4. Marty Makary will stand up to other administration leadership, potentially RFK, in at least one key way.
- 5. At least one major FDA leadership departure probably in the biologics sphere. During the first Trump term, some FDA leadership stayed and persevered. Sometimes bending to let politics sway decisions. I expect that to continue in Trump 2.0, but for some FDA leaders it’ll be too much and they’ll leave.
Unproven stem cell and ‘regenerative medicine’ clinics
- 6. At least one more criminal case against a purveyor of unproven regenerative offerings. In 2024 we saw the Liveyon leader get 3 years. I expect in 2025 there will be one or more additional criminal cases. This could be at the state level.
- 7. Regenerative clinic chains 1: I predict we’ll see more news in 2025 about the large regenerative chain QC Kinetics.It could be related to the patient class action suit against it.
- 8. Regenerative clinic chains 2: I predict Cell Surgical Network will be in the news related to the court case with the FDA. A key question is whether the full 9th Circuit Court will opt to view the appeals case in which a 3-judge panel ruled for the FDA. My more specific prediction is that one way or another, the FDA will prevail here. This seems likely given the 11th Circuit ruling on a similar case where the FDA won.
- 9. Regenerative clinic chains 3: I predict we’ll see more news in 2025 about the third large regenerative clinic chain, R3 Stem Cell. In my view this clinic group raises a number of concerns.
- 10. Media and Google continue promoting unproven biologics clinics. Unproven clinic promotion by local TV stations and large media outlets will remain problematic. We even saw the Associated Press promoting unproven stem cell clinics via posting press releases. Google is likely to continue promoting unproven stem cell clinics through its inaccurate search results and its inaccurate AI summaries. Google really seems not to care about public health.
- 11. More state AG activity on unproven stem cells and biologics. State Attorneys General have been doing a great job of tackling unproven clinics recently. I see that continuing in 2025. The contrast between state AG and federal oversight (as well as anemic-to-non-existent state medical board activity) could become more stark toward the second half of 2025.
Nucleotide tidings in the regenerative medicine sphere
- 12. Unproven oligo therapies make more news. More developments on unapproved and unproven oligonucleotide therapies like SOT or supportive oligonucleotide therapy.
- 13. He Jiankui continues trying to make a comeback or is otherwise in the news. Unfortunately, he’ll likely continue to be in the news.
- 14. Liz Parrish and/or BioViva or other unproven gene therapies including DIY efforts will stay in the news.
- 15. I still believe RNAs as medicines is an exciting area and predict we’ll see more on that in 2025.
Adult stem cell developments
- 16. More drama from Cryo-Cell and Duke including related to their partnership on cord blood cells. I predict Cryo-Cell will not open its planned infusion clinic in 2025, which in my view is good news. Charging families for unproven cord blood, especially given so much negative data out there, is not right in my view. Note that while umbilical cord cells are not actually adult stem cells in one sense (they are fetal cells), they are widely considered a type of adult stem cells. Perhaps meaning not pluripotent.
- 17. More encouraging news on at least one and probably more adult stem cell clinical trials. As I’ve written many times, I don’t favor any one particular type of stem cells. If adult stem cells or related cells like MSCs can be proven to work and be safe, that’s good news in my view.
- 18. At least one and probably more Republicans will push for some unproven biologics, probably adult stem cells. These cells or cell therapy products like exosomes may be made or sold by a clinic-related firm.
- 19. States challenge the FDA on adult stem cells, etc. We’ll see more state bills or laws giving the green light to non-FDA-approved biologics, probably including stem cells. We’ve already seen a risky Utah stem cell law and a Nevada law that directly challenge the FDA on cells and even unproven nucleotides (which may apply to SOT, which I mentioned above.) These laws mainly seek to advance firms selling unproven adult stem cells. There may even be talk of or steps toward a national law weakening FDA oversight.
Longevity space as part of regenerative medicine
- 20. More longevity hype. The longevity or anti-aging enthusiasts will continue in their overexuberance.
- 21. David Sinclair will stay in the news on longevity.
- 22. We’ll hear about at least one more major in vivo reprogramming effort, maybe from Altos Labs.
Pluripotent stem cells
- 23. We’ll see more encouraging/good news on regenerative research for Parkinson’s disease.
- 24. More encouraging/good news on vision research including in Japan. This may involve both adult stem cells and pluripotent cells.
- 25. More encouraging/good news on cell therapy for diabetes research, probably from Vertex.
Do you have any predictions for the new year? Let us know in the comments.