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Wednesday, 05/11/2011 7:30:19 PM

Wednesday, May 11, 2011 7:30:19 PM

Post# of 92948
For those mailing questions about time frames for possible trial results, here is a response from CEO on topic.

Posted by ACTC_Fan at InvestorStemCell

Clarification from Gary about timing of trial data being released
I emailed Gary requesting some clarification on the timing of trial data being released and received the below response. (along with his permission to publish the response here) Very nice of him to take the time out to clarify this, much appreciated. Thanks to abr for providing me his email.

______________________________
Hello *****,

Thanks for your questions. The Phase 1 trial endpoints are, by definition, safety endpoints (e.g., no teratomas, no ectopic tissue, no severe retinal damage, no immune rejection issues, etc.). However, because of the nature of the auto-fluorescence and OCT imaging we can do, we hope to be able to demonstrate the kind of engraftment that we have seen in our animal models (see slide 14 from my discussion). Certainly, the patient selection of the first cohorts in the trials, particularly of the AMD patients (who will tend to be elderly with severely deteriorated sight) may impact our engraftment viability. For this reason, the early results should not be viewed as a clear window into the ultimate efficacy of the study, but we want to provide as much transparency as possible to the investors into our results.

We plan to release patient data after the first three patients in each trial have had at least 6-8 weeks of post-injection experience (so roughly 3-3.5 months after first patient treatment).

I hope this answers you.

Best,

Gary
_____________________

http://investorstemcell.com/forum/advanced-cell-technology/1855.htm

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