Grading my 25 stem cell & regenerative medicine predictions for 2025

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 in some form for more than a dozen years. In today’s post I grade my 2025 predictions for the regenerative arena.

Overall, the crystal ball didn’t disappoint even if the actual 2025 news was sometimes discouraging. Still, there were also some positive surprises. Stay tuned for my 2026 predictions, which are coming soon.

Grades for 2025 regenerative medicine and stem cell predictions

I’ll start with stem cell predictions I made related to the FDA for last year. Note that each prediction comes first and then the grade with a bit of explanation. In some cases I’ve shortened the predictions here for brevity. For the grades, red is wrong, orange is partial credit, and green is right.

FDA under year one of Trump 2.0

• 1. Less FDA oversight activity.  Correct. The FDA and CBER have done less in the biologics space than in 2024. Despite the reduced oversight, the agency did send off a solid number of warnings in the perinatal space. I saw that as good news and to be honest I didn’t predict that extent of activity. Kudos to CBER for this continued activity.
• 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. Wrong. I still think RFK Jr. can’t last four years as these guys are like oil and vinegar, but we’ll see how far it goes. 
• 3. At least one and maybe more key FDA approvals of a regenerative medicine product, probably Mesoblast. 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. Correct. I got this one right on Mesoblast faster (mid-December last year but after my predictions) than I imagined. Makary is FDA commissioner.
• 4. Marty Makary will stand up to other administration leadership, potentially RFK, in at least one key way. Correct. I got this one right but it’s complicated. While Makary stood up to Trump on getting Vinay Prasad back after he was ousted, I don’t know that he’s really stood up to Kennedy.
• 5. At least one major FDA leadership departure probably in the biologics sphere. Correct. Too correct. Who’s left anymore? Prasad even left and then came back.

Unproven stem cell and ‘regenerative medicine’ clinics

• 6. At least one more criminal case against a purveyor of unproven regenerative offerings. Correct. Three people were recently charged with felonies in Utah related to actions at a stem cell clinic.
• 7. Regenerative clinic chains 1: I predict we’ll see more news in 2025 about QC Kinetix. It could be related to the proposed, reported patient class action suit. Partially correct. The firm made news on relaunching its franchising. Admittedly, I was thinking there might be bigger news.
• 8. Regenerative clinic chains 2: I predict Cell Surgical Network will be in the news related to the court case with the FDA. My more specific prediction is that one way or another, the FDA will prevail here. Correct. The defendants asked SCOTUS to look at the stem cell case, but it didn’t happen.
• 9. Regenerative clinic chains 3: I predict that we’ll see more news about R3 Stem Cell. Partially correct. The big story here is how widespread R3 promotion has been within mainstream media outlets that are putting out material that seems like news. See item #10 below.
• 10. Media and Google continue promoting unproven biologics clinics. Correct. This trend just keeps getting worse. 
• 11. More state AG activity on unproven stem cells and biologics.  Correct. There were several instances of positive news on AG actions on stem cell clinics this year. For example, the Iowa AG settled a case against stem cell clinics there. Also, the Georgia AG won a $5.1 million settlement on stem cell clinics there. I also saw this: Arizona AG sues umbilical cord blood registry over alleged scam. Now in late 2025, the Iowa AG won again on unproven stem cells with a $1M settlement. A big shoutout to the state AGs, both Republicans and Democrats, for making such a difference protecting consumers.

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. Correct. SOT therapy has been rebranded in 2025 as Q-REstrain. The rebrand would have been sparked in part by European regulatory action related to SOT. In my view, the FDA needs to take action here.
• 13. He Jiankui continues trying to make a comeback or is otherwise in the news.  Correct. He’s blasting out tweets, including some that seem way over the top. He’s wife or ex-wife Cathy Tie also started the Manhattan Project to make CRISPR babies to avoid genetic diseases. He Jiankui reported having a lab in the US.
• 14. Liz Parrish and/or BioViva or other unproven gene therapies including DIY efforts will stay in the news. Correct. George Church, a BioViva advisor, and Parrish had a key paper retracted.
• 15. I still believe RNAs as medicines is an exciting area and predict we’ll see more on that in 2025. Correct. Scientists remain legitimately excited about RNA as a type of medicine, but some have tried to politicize and demonize mRNAs. This political activity is a setback, but RNAs are still a promising type of emerging medicine and some have been proven to work. I like to remind people that we humans are full of RNA, probably almost a pound of it.

Adult stem cell developments

• 16. More drama from Cryo-Cell and Duke including related to their partnership on cord blood cells.  Correct. The entire Duke Cryo-Cell deal collapsed. You can’t get much more dramatic than that.
• 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. Correct. I’m glad we have all kinds of stem cells showing promise in clinical trials. In a recent paper adult stem cells seemed promising in a trial for corneal issues. See #24 below.
• 18. At least one and probably more Republicans will push for some unproven biologics, probably adult stem cells. Correct. This one was accurate on several levels. There’s RFK Jr., of course, if one considers him a member of the GOP. There are the Republican-pushed state laws (see below) saying FDA approval isn’t needed for unproven stem cells. The list goes on.
• 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. Correct. Look at the Florida stem cell law.

Longevity space as part of regenerative medicine

• 20. More longevity hype. The longevity or anti-aging enthusiasts will continue in their overexuberance. Correct. How has 2025 been able to be even worse than 2024 on this front?  I don’t know, but it was. I’m glad to see more pushback on this at least.
• 21. David Sinclair will stay in the news on longevity. Correct. This one is another one of those that is technically right, but I did expect more news on his research and interest in his statements on longevity. About a year ago I wrote about Charles Brenner challenging Sinclair including on claims in a Cell paper.
• 22. We’ll hear about at least one more major in vivo reprogramming effort, maybe from Altos Labs. Correct. Things were somewhat chaotic in this space. There was Shift Biosciences and there secret rejuvenation molecule SB000. That was just a preprint but it got people’s attention. There was YouthBio Therapeutics with its own “youthifying” approaching, YB002, based on the Yamanaka factors.  Here again I thought we’d see more though including some higher-profile papers.

Pluripotent stem cells

• 23. We’ll see more encouraging/good news on regenerative research for Parkinson’s disease. Correct. I wrote back in April about three promising clinical trial results on stem cells for Parkinson’s. One of the firms, Aspen Neuroscience, also raised more than $100M this year.
• 24. More encouraging/good news on vision research including in Japan. This may involve both adult stem cells and pluripotent cells.  Correct. Japan continues to produce great clinical trial work. We also saw this Cell Stem Cell paper in November that is exciting: Safety and tolerability of RPESC-RPE transplantation in patients with dry age-related macular degeneration: Low-dose clinical outcomes.
• 25. More encouraging/good news on cell therapy for diabetes research, probably from Vertex. Correct. The news this year on Vertex’s Zimislecel is very exciting. Most participants who got the investigational cells in a small trial could stop insulin. I’m eager to see more and longer-term data to see how this holds up.