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reshamn replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years ago
CAR-T therapy is an upcoming cellular therapy to treat cancer. It has been recently shown to be successful with ALL patients. However, this wasn’t the case in July 2016 Leukemia CAR-T trials. Three adult leukemia patients died in a trial of a new cellular-level medicine, CAR-T. Patients experienced cerebral edema. The sponsoring medical professionals were from Juno. Although, they argued that cerebral edema is an expected reaction to these types of patients, but the trials were halted and in under FDA review.