FDA Gives TCA Cellular Therapy Green Light to Proceed with First ALS Adult Stem Cell Trial Using Patient’s Own Stem Cells

TCA Cellular Therapy announced last week that the FDA had approved its protocol to conduct a Phase 1 clinical trial for ALS. This is the first FDA-approved protocol that will allow a trial of stem cells using the patient’s own cells. Cellular biologist Jose J. Minguell, Ph.D., will administer the process of removing adult stem cells from the patient’s bone marrow in an outpatient procedure. The cells will then be processed in TCA’s lab and re-inserted in the patient by spinal tap. Patient recruitment will begin in the next few weeks, and TCA Cellular anticipates moving into Phase 2 trials within the year.

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