Accelerated Filers: 10-Q: for Quarterly Period Ended 06/30/11 due Tuesday, August 09, 2011
"When are the next patients allowed in?"
The 2 patients that received injections on July 12 will be reviewed by DSMB at 6 weeks. How long review takes I don't know. DSMB review should take place around August 24.
" rock, I don't get what was injected. The MA09 RPE's are embryonic, right?"
No, terminally differentiated RPE's DERIVED from MA09 hESC cell line. The paragraph from Caldwell below best defines what took place, the RPE's injected would be the "butterfly". Hope that helps you, it did me.
We develop a stem cell line. In the current example of the derived RPE cell line, the embryonic cell line utilized our single blastomere technology. It was one of the first lines we developed. We utilize Good Manufacturing Practices to develop what is called a “Master Bank” of human embryonic stem cells. These cells are characterized and tested to insure they are truly hESCs. You should know that one of the scientific tests to determine that the cells are hESCs, is whether they can produce a teratoma or benign tumor. ALL hESCs must be able to do this. We then develop a “working bank” of these cells. They in turn are differentiated into a particular cell type. In this case, RPE cells. We develop a “master bank” of RPE cells, again utilizing Good Manufacturing Practices in our lab in Worcester. That Master Bank of RPE cells is characterized, tested for purity and is worked to the point where it is “terminally differentiated”. Meaning that they can NO LONGER revert back to an embryonic state. The best example I can think of it that: It is now a butterfly and NOT a caterpillar. We test the RPE cells for purity and to insure that NO residual embryonic stem cells still exist. They must be 99+% pure with no lingering hESC’s, period!" http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53531326
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