My stem cell predictions for 2013

Stem cell predictions
Stem cell crystal ball for predictions.

In previous years I’ve done yearly predictions for the coming year’s events in the stem cell world (see predictions for 2011 and 2012 predictions). I did pretty well in my predicting stem cell events for this year (see analysis here) scoring a respectable 70%. Isn’t that a C-?,you might ask. No, when it comes to stem cell predictions anything better than 50% is an A.

Below are my prognostications for the stem cell field for 2013. I’m taking some more risks this year, but you only live once, right?

10. At least two new lawsuits are filed against stem cell businesses, most likely by patients. I think the number is more likely to be 3-4, but let’s see what develops.

9. No human iPS cell clinical trials start in 2013. More likely to begin in 2014, which will be exciting. I think this is actually good news compared to moving too fast.

8. Transdifferentiation makes a major advance.

7. A controversy emerges related to anti-embryonic stem cell research folks. For example, something pops up related to 2013 Vatican stem cell meeting or pro-life stem cell folks being tied to the for-profit adult stem cell industry.

6. Celltex moves part of its business to Mexico or another overseas location. This move may manifest in them routinely shipping patients’ stem cells out of the U.S. to be transplanted by doctors into patients in other countries. A big question is whether any transplants of Celltex stem cells will take place at all in the U.S.

5. A surprising development occurs related to another state stem cell agency other than CIRM.

4. Some clinically relevant and meaningful pre-clinical data are published on transplants of human iPS cells that is encouraging for potential future clinical safety or efficacy.

3. ACT’s clinical trials for multiple forms of macular degeneration continue without any major hiccups. Safety well-established, the focus turns to efficacy looking to 2014. The stock PPS? I won’t hazard a guess.

2. More FDA regulatory actions take place versus unlicensed stem cell companies in 2013 compared to an already increased number in 2012 and also additional indictments filed against stem cell bad actors.

1. The Supreme Court takes a pass on Sherley v. Sebelius, leaving federal funding of human ES cell research firmly in the “legal” category.

A year from now we’ll see how I’ve fared….

15 thoughts on “My stem cell predictions for 2013”

  1. Pingback: How’d stem cell predictions for 2013 fare? | Knoepfler Lab Stem Cell Blog

  2. Pingback: Transdifferentiation makes a major advance: direct reprogramming of fibroblasts to oligodendrocyte progenitors | Knoepfler Lab Stem Cell Blog

  3. Paul,
    Re: 7. A controversy emerges related to anti-embryonic stem cell research folks. For example, something pops up related to 2013 Vatican stem cell meeting or pro-life stem cell folks being tied to the for-profit adult stem cell industry.

    Fascinating. Possible issues related to the claims of companies about very small embryonic like stem cells?

  4. My bets:
    10. More than 2
    9. commented above
    8. Depends what you mean under “transdifferentiation”. Spontaneous in vivo, induced by defined factors in vitro or in vivo. The major advance could be a clinical trial. I think it’s too early for the trial, but we can get close to it.
    6. Very much possible. But if they really care about future and reputation, they will do clinical trials via IND in US – could be in parallel with injections in Mexico though.
    5. Texas? Have no idea
    4. A few pre-clinical models for iPS cell-based therapy were published this year already. Next year will be much more, of course…
    3. Agree, they will go smoothly
    2. I think, will be the same as in 2012. FDA has no muscles to inspect and watch all of these over-proliferated guys, unless they will expand of cell therapy CBER branch, but i don’t think so.

  5. Re: No. 9 — Riken, in Japan has announced that they intend to begin human clinical trials using iPSCs to generate RPE for AMD in ophthalmology in 2013. We’ll see if they get there.

    1. Both RIKEN and ACT announced that they are applying for the first iPS cell trial ever – in Japan and US. The big question will regulators give a green light for it in 2013.
      My bet – yes for RIKEN at the end of the year. No from FDA to ACT.

  6. Thanks Paul, another top post, as an Advanced Cell Technology investor and follower, I too wouldn’t dare to name a pps figure.

    I would dare to suggest, though, that regenerative medicine makes a dramatic leap forward in 2013 with FDA fast tracking ACT’s RPE cells for Stargardts Macular Degeneration. What do you think about this possible development?

    1. I think, FDA will clear Ph2 after reporting of results Ph1, but it will not be fast track. Fast track is given to orphan indications or if trial is demonstrating 100% efficacy in Ph2 = all patients have remarkable response to therapy + it’s life-saving.

      1. Hi Alexey, thanks for your response, I forgot to add in my post that ACT has been awarded Orphan Status for SMD in the US and I think Europe, all patients have shown attachment of injected cells, the first 2 patients continue to show improved vision 18 months after their injection, all patients show improved visual acuity, and although SMD is not life threatening it is the single most unmet need in the world, blindness.

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