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Post by forthefuture on Jan 5, 2015 5:20:59 GMT
Alexey Bersenev, cell scientist at Upenn runs a stem cell blog. Thought his blog on cell trial failures might be of interest to folks. One thing that stood out to me was the # of MSC trials that are failing. Lanza is stating Ocata's cells are more efficacious and easier to manufacture in mass quantities. I hope they're able to prove these in human trials. That said, I think these trial failures are some of the reasons why cellular therapies are having a hard time gaining legitimacy in the eyes of institutional investors and to some extent, big pharma - positive animal preclinical trials are leading to negative to mixed results in the clinic. celltrials.info/2015/01/04/failures-2014/ |
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Post by kukkido on Jan 5, 2015 6:47:53 GMT
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Post by ymc on Jan 5, 2015 10:59:52 GMT
Alexey Bersenev, cell scientist at Upenn runs a stem cell blog. Thought his blog on cell trial failures might be of interest to folks. One thing that stood out to me was the # of MSC trials that are failing. Lanza is stating Ocata's cells are more efficacious and easier to manufacture in mass quantities. I hope they're able to prove these in human trials. That said, I think these trial failures are some of the reasons why cellular therapies are having a hard time gaining legitimacy in the eyes of institutional investors and to some extent, big pharma - positive animal preclinical trials are leading to negative to mixed results in the clinic. celltrials.info/2015/01/04/failures-2014/Posted by kukkido3 hours ago
Anyone see this yet? celltrials.info/2015/01/02/top-10-cell-therapy-2014/ Kukkido celltrials.info/2015/01/02/top-10-cell-therapy-2014/Top 10 cell therapy clinical studies in 2014
by ALEXEY BERSENEV on JANUARY 2, 2015 · 0 COMMENTS
in UNCATEGORIZED
At the end of the year I analyze results of clinical studies in cell therapy. Today, I’d like to highlight 10 most significant, in my opinion, clinical studies with published results. Taking in account excellent safety profile of most cellular therapies, I was trying to focus on efficacy and long-term outcomes. Do cells really work? That’s what we are care about. Please discuss your favorite (published) clinical studies from 2014 in comments!
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1. First results of embryonic stem cell-based trial
Since first isolation of human embryonic stem cells (ESC) in 1998 and approval of the first clinical trial by FDA in 2010 (Geron corp.), we have been waiting any safety results after transplantation of this type of cells into human. Finally, this year, preliminary results of Phase 1/2 clinical trials, conducted by Ocata Therapeutics in US, were published. The authors concluded that transplantation of ESC-derived product into the eye is safe in mid-term (up to 3 years). I think, this is single most significant clinical study in the whole history of embryonic stem cell field.Great posts from both FTF and Kukkido referencing articles on the failures and successes of SC trials. Please also see Bersenev's " Cell therapy trials failures in 2013 by ALEXEY BERSENEV on DECEMBER 25, 2013" and the 3 COMMENTS, including his response regarding his optimism in SC therapies despite some trial failures. We certainly need to keep things in perspective, i.e. cautious optimism, and the great promise of MSC might need to be dialed down a little. celltrials.info/2013/12/25/failures-2013/"Alexey Bersenev January 16, 2014 at 11:37 am
Hi Iwona,
I don’t think it’s disappointing, but opposite. I compare it with Pharma/ Biotech failure rates and I see that cell therapy as new industry does much better. I cover almost all (or 70-80%) of failures from 2013 and I focused on Phase 2 design.
If cell therapy Phase 2 success rate will be 30-60% it will be so great! I don’t have number yet, but it’s doable.
I did not list all trials, which succeed, because there are so many! As I note in the post, almost all cell therapy trials pass Phase 1. I’d expect success rate for Ph1 >85-90%. I don’t have time to do analysis of all these, because I don’t have full time job. But I’d be happy if someone can do this analysis and show us statistics. I called for collaboration on this matter 2 years ago, but didn’t get any responses. You can track all of these reports yourself and share analytics or you can follow my tracking and use it for analysis.
I track almost all reports real time here – twitter.com/#!/CellTrials" |
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Post by ymc on Jan 5, 2015 11:13:10 GMT
Moderators, maybe this thread should be modified to say "Blogs on Cell Trial Failures and Successes", and maybe make it a sticky also!??!
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Post by iamaverb on Jan 5, 2015 14:10:56 GMT
"Since first isolation of human embryonic stem cells (ESC) in 1998 and approval of the first clinical trial by FDA in 2010 (Geron corp.), we have been waiting any safety results after transplantation of this type of cells into human. Finally, this year, preliminary results of Phase 1/2 clinical trials, conducted by Ocata Therapeutics in US, were published. The authors concluded that transplantation of ESC-derived product into the eye is safe in mid-term (up to 3 years). I think, this is single most significant clinical study in the whole history of embryonic stem cell field." |
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Post by rickrick on Jan 6, 2015 11:40:41 GMT
Moderators, maybe this thread should be modified to say "Blogs on Cell Trial Failures and Successes", and maybe make it a sticky also!??! I made it into a sticky but I'm unable to alter the title. |
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Post by JHam on Jan 6, 2015 12:15:46 GMT
Moderators, maybe this thread should be modified to say "Blogs on Cell Trial Failures and Successes", and maybe make it a sticky also!??! I made it into a sticky but I'm unable to alter the title. Done. You have to edit it through the first post in the thread. |
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Post by manzarm on Aug 5, 2015 12:02:35 GMT
nice info.
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