How many subjects are to be enrolled per Clinical Center?
The number of subjects to be enrolled per center depends on the protocols proposed, the availability of patients to be recruited, and the funds available for clinical studies. There is no prescribed minimum or maximum number of subjects to be enrolled. Epidemiologic studies or Phase III clinical trials are not responsive to this RFA. The applicant must indicate for each clinical cell therapy protocol how many patients are available in the applicant’s center and how many will be required from the entire Network.