Description
This leukapheresis study proposes to continue our work in developing and optimizing our Treg manufacturing process. Under this study, up to 10 patients with ALS will undergo leukapheresis. Their Tregs will subsequently be isolated and expanded from the leukapheresis product in the cGMP facility at Houston Methodist Hospital in order to develop and validate the Treg manufacturing process for the ultimate purpose of obtaining FDA approval in future trials. Once FDA approval is obtained, the Treg manufacturing process will be utilized in upcoming clinical trials in patients with ALS to be submitted under different FDA submissions and IRB protocols. There is no plan to treat any patients under this specific protocol.
