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Re: interstate post# 32057

Thursday, 05/26/2011 9:34:22 PM

Thursday, May 26, 2011 9:34:22 PM

Post# of 92949
interstate,

good post. Minor correction, it is 6 weeks after 1st patient and 4 weeks after 3rd patient. Thanks again

dryAMD:
"Six weeks after the first patient in each dose cohort receives the cell transplant, the DSMB will review the clinical data and recommend if the next two patients in the dose cohort may be treated. Each cohort of 3 patients will be reviewed by the DSMB when the 3rd patient completes 4 weeks of follow-up.

SMD:
"Patients will be enrolled sequentially, and within each cohort of 3 patients, each patient's clinical course over the first 6 weeks following cell transplantation will be reviewed by an independent (DSMB) before enrollment is opened for the next 2 patients. A full safety assessment of all 3 patients in each cohort will be made by the DSMB when the 3rd patient in each cohort completes 4 weeks of follow-up, and before the first patient in the next cohort receives a cell transplant."



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