Text and Data Mining valid from 2020-04-21
Received: 22 January 2020
Accepted: 2 April 2020
First Online: 21 April 2020
Ethics approval and consent to participate
: The randomized clinical trial was conducted per the Declaration of Helsinki after approval by the Western Institutional Review Board (Seattle, WA., ID 2009 0753), and in accord with assurances filed with and approved by the Department of Health and Human Services. All patients gave written informed consent prior to randomization. In addition to Institutional Review Board oversight, conduct of the trial was monitored by an external consultant, and Hoag Hospital’s institutional clinical research oversight committee. The protocol and manufacturing procedures were reviewed by the US Food and Drug Administration in association with BB-IND 5838 for the tumor cell vaccine, 8554 for the dendritic cell vaccine.
: Not applicable.
: GIN and ROD are both employees of AVITIA Biomedical, Inc.