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Article History

Received: 15 February 2023

Accepted: 11 August 2023

First Online: 22 August 2023

Declarations

:

: The study protocol, titled “An open-label, standard treatment as a control, multicenter phase II study to evaluate the efficacy and safety of HLCM051 (MultiStem^®) in patients with acute respiratory distress syndrome (ARDS) caused by pneumonia”, and addendum were approved by the ethics review board of each site (details of the approval committees, dates, and approval numbers are provided in Additional file : Table S1). Written informed consent was provided by the patient or his/her legal representative if required due to sedation, etc.

: Not applicable.

: The funding body, Healios K.K., was involved in the study design, data collection, data analysis, and preparation of the manuscript. HI, TJ, KF, SN, and ST received support for their advice and/or evaluation of safety/imaging/extubation from Healios K.K. KI received fees from Healios K.K. during the conduct of the study and reports speaker fees and research funding from Boehringer Ingelheim. T. Kotani received fees from Healios K.K. during the conduct of the study and reports fees from Toray Medical for the development of ARDS treatment. YK received consultancy fees from Healios K.K. during the conduct of the study and serves as a consultant to Asahi Kasei Pharma Corporation, Shionogi & Co., Ltd., Boehringer Ingelheim, Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd.; and has received lecture fees from Asahi Kasei Pharma Corporation, Shionogi & Co., Ltd., Boehringer Ingelheim, AstraZeneca K.K., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Bristol-Myers Squibb, Kyorin Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., and Teijin Pharma Limited. T. Kawayama received fees from Healios K.K. during the conduct of the study and reports lecture fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Novartis Pharma K.K., Teijin Home Healthcare, Sanofi, Kyorin Pharmaceutical Co., Ltd., and Meiji Seika Pharma Co., Ltd. MS is an employee of Healios K.K. EJ is a former employee of Athersys, Inc. (manufacturer of invimestrocel), and is an employee of Kiniksa Pharmacueticals. SH has received study funding from JMS Co. Ltd., advisory fees from Healios K.K., lecture fees from Fukuda Denshi Co., Ltd., Covidien Japan Inc., and Philips Japan, Ltd., and was an editorial committee member for the clinical practice guideline for the management of acute respiratory distress syndrome in The Japanese Society of Intensive Care Medicine, a chairperson of the ICU Collaboration Network, and is a board member of the Japan ECMOnet.