First results of embryonic stem cell trials

by Alexey Bersenev on October 14, 2014 · 1 comment

in cell product

Post to Twitter Send Gmail Post to LinkedIn

Today – October 14 of 2014 is a very important day in “stem cell history”. US-based company Advanced Cell Technology (ACT) released results of the clinical trials, where embryonic stem cell-derived product was tested in patients with macular degeneration. The first ever peer-reviewed results of FDA-approved clinical trials, involved use of embryonic stem cells (ESC), published online in Lancet (keep renewing your browser window until Lancet will put abstract in). You can download article here. This is a big milestone in stem cell research and cell therapy industry! I think, it’s probably the most important event of the year so far! Here is why:

  1. Out of few, approved by federal regulatory agencies, ESC-based trials, none results were published in peer-reviewed literature until now (I don’t count Asterias PR and ACT two cases report).
  2. Everybody were eagerly awaiting for results of safety profile of ESC-based therapeutic. ACT’s study concluded that ESC-derived product is safe during observation time of 2 years. Study is feasible.
  3. Even though, trials were not design to assess efficacy, more than half of patients demonstrate different degree of improvement of sight.
  4. There were some signs of engraftment of ESC-derived cells in more than half patients. That’s what we are missing in “adult stem cell studies”.
  5. Despite criticism and some critical financial periods, ACT was able to conduct/ complete the trials and report results. ACT shows – it’s possible! What a courage and inspiration for others! No matter how the next phase will progress, ACT is blazed the trail for other developers.
  6. With positive data, this study is triggering a new wave of interest to embryonic stem cell-based therapies.

Now, some considerations against premature hype:

  1. The report is not final, but interim. Patients from 2 separate trials (NCT01345006 and NCT01344993) were combined for analysis. Each trial has an enrollment goal of 16 patients by the end of this year. So data could change when all patients will be analyzed.
  2. Two years is mid-term observation, but long-term follow-up (10-15 years) is required to conclude safety of ESC-derived products. And… yes – we still don’t know the efficacy until Phase 2 will be concluded.
  3. Some complications were reported in the study (but not in official company’s PR and mass media coverage): 4 eyes had significant progression of cataract, requiring surgery 6-12 months after cell therapy, 1 patient developed bacterial eye infection 4 days after cell therapy, 1 eye – “sterile inflammation”, 1 eye – subretinal bleb. All complications were resolved and did not lead to enucleation. There was no evidence for direct relation to a product, but seem like complications were procedure-related (surgery).
  4. Instead of paying much attention to PR and mass media coverage, I’d encourage you to read an article and do your own assessment.

*******************
PS: I do not have any conflicts, related to ACT.

{ 1 comment… read it below or add one }

tonyon February 20, 2017 at 6:32 am

…future travel (without false freedom)… Silence is golden?…”rosse-tie” passive homo-vice, “bluesss skysss-tie” active homo-vice from the “facestifffinger”. The apostles of the inhuman homo-vice, with their propagator acolytes “maricones” and “tortilleras” in news TV installed announcing “happy” their days of “pride”, infecting colors, numbers, words… Nobody yet perceives what it pretend the fetid homo-vices (“maricones”) with from technology use degenerated: go artificially pregnant and throw their “sons” by where go out the fetid excrement to that unworthy and horrible ill world, a world without women where nobody will can live with dignity. Homo-vices, religious, have the control of all Global Media: Internet, TV, radio, movies, newspapers…see, besides of look, constantly in Hollywood-movies, South American TV-novels and TV programs role of evilness against beautiful innocent actress, role of “goodness” for man-actor, violence, crime and insults against women, for that after will be reality passing from fiction to real life (what´s to see, is what´s to do). And nobody in the entire World says anything, nor do people, nor do politicians, nor do nobody. Only hypocrisy and lies and silence, with “marymales” occuping almost each National Presidency reclaiming “free sex orientation”…because if anybody says anything does not can have a job, or something worse… Silence is golden?, NOT. It´s time for to say the truth, for the wellness of Future´s Humankind.

Reply

Leave a Comment

Previous post:

Next post: