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.
Do you know what a safety study is and how it is conducted? Too small a dose(but we hope it might do some good) but large enough to see if there are side effects. With eyes the docs can look in and see what is happening. They are MOSTLY looking for bad stuff. If good stuff happen that is a good thing.
Good post Roy! No doubt the trials are going at least Ok or we would not have gotten more patients. This is all the scraps of trial news we may get for a while, but it is reasonable to interpret this news positively.
While reading Maurie's 9/24 article, there's a link ProgStar, they are going to suggest to Stargardt's patients which trial they should enter. Things should start to move faster w/ those recommendations.