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FDA's Official Reasons: Lack of Clinical Trials: The FDA emphasizes the need for extensive, controlled clinical trials, which are currently lacking

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When fully dissociated, cells were centrifuged (230 g , 3 min) and the cell pellet resuspended and diluted to approximately 2.5E06 cells/mL in Recovery TM Cell Culture Freezing Medium (Gibco, #12648-010)