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rocky301

09/28/11 9:13 AM

#34127 RE: cty #34125

cty,

one patient from each cohort of each trial was treated first.
Each cohort has 3 patients per trial.

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
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interstate

09/28/11 10:09 AM

#34138 RE: cty #34125

straight from clinicaltrials.gov

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.