Key questions for stem cell field bouncing around on a Friday morning

By / 7 Comments / February 1, 2021 / act, Athersys, BioGatekeeper, FDA fast track, FDA stem cells, iPS cells, NeoStem, Right To Try Laws, Right-To-Try Law stem cells, stem cell biotech's, stem cell paper retractions, stem cell questions, StemCells Inc, Viacyte, Yamanaka Patent / Blog, stem cell news, stem cell politics

What are the most interesting questions for the stem cell field in 2014 right now?

What’s on your mind?ViaCyte New Logo

I’m not going to give this deep thought, but rather just list those questions bouncing around at the moment in no particular order. You can see a lot of translational/clinical things are on my mind. I’ve put possible answers, but these are highly speculative and/or based on hope in some cases.

  • What’s next for ACT’s hESC-based clinical trials and Takahashi’s iPS cell-based clinical study for macular degeneration? I’m optimistic on safety for ACT and hopeful on efficacy, while it’s harder to predict for the iPS cell study.
  • How will ViaCyte‘s new early hESC-based trial for Diabetes go? I’m cautiously optimistic.
  • In a year, where will the iPS cell IP/patent arena stand and who is BioGatekeeper? I expect no more clarity in a year overall, but BioGatekeeper will be outed by then or much sooner.
  • Will the trend of for-profit networks of stem cell clinics exploding across America continue? Unfortunately, yes.
  • Is the FDA planning to get back into the ballgame of regulating such stem cell clinics or has it punted due to (fill in the blank: budget problems at the agency, other priorities, a change of philosophy, etc.) Who knows? It’s been a disappointing year for the agency in this area.
  • Will the FDA apply Fast Track, Accelerated or Priority Review or Breakthrough Therapy Designation to any emerging stem cell products? It’s about time. They should.
  • What will the impact of the likely growing number of state Right To Try laws be? I expect it will increase both risk and innovation, but unfortunately much more of the former than the latter.
  • Was the flood of very high profile stem cell paper retractions so far in 2014 an aberration or will it painfully continue? I hope it does continue, but it’s a worry as the field needs public trust and respect.
  • Will a big pharma acquire a small biotech like Athersys, ACT, StemCells, Inc., Neostem, in the coming year? More money is sure flowing from big to small (witness ViaCyte’s new influx of money) and we saw this with happen California Stem Cell. I think we’ll see this trend of money flow or even acquisitions accelerate although there are structural obstacles to being acquired for certain companies. 2020 update: Of the companies in the bolded part of this bullet point, only Athersys remains.

What questions are on your mind right at the moment related to stem cells and regenerative medicine?

Note this post is simply informational and is not financial advice. Only make financial decisions after consulting with a certified financial planner, which I am definite not. I hold no stake in any of the companies mentioned.

7 thoughts on “Key questions for stem cell field bouncing around on a Friday morning”

  2. SoCalLocal

    “The “credibility” problem is caused by non-hESCs that became fashionable only as a desperate alternative to a banned science.”

    Sure.

  3. Ray Gordon

    No one will buy out ACTC because they’d start a bidding war and destroy the appreciation they could enjoy with a JV and owning 40 percent instead. Pfizer is already doing research in an area ACTC patented, so if they want to commercialize that they will have to license ACTC’s technology, and GE just opened a stem-cell plant in AcTC’s back yard. The “credibility” problem is caused by non-hESCs that became fashionable only as a desperate alternative to a banned science. ACTC stayed that course and now has a patent sweep. If REGN is worth $34b off Eylea than ACTC is worth at least that off MA-109.

  4. sandy9tj

    When will the NIH approve ACTC’s non-embryo destroyed (NED) line. This would and should quite the controversy of conducting embryonic stem cell research.

    1. admin

      I’ve been wondering the same thing. It’s a very strange situation as to why NIH would not have done this already. There are some various theories circulating that are concerning…

  5. Chris

    My question: when iPSCs are edited to correct, say, a B-thalassemia mutation and then differentiated toward HSCs, they retain expression of the fetal hemoglobin, HbF. How do we interpret this finding and are there clinical applications that might be exploited based on this reactivation?

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