Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial

• Akihiro Hirakawa,
• Masahiko Ando,
• Masahiro Hayakawa,
• Nao Matsuyama,
• Shinobu Shimizu,
• Kazuto Ueda,
• Toshihiko Suzuki,
• Sakiko Suzuki,
• Ryosuke Miura,
• Akemi Katayama,
• Masaaki Mizuno,
• Yoshiaki Sato

Affiliations

Akihiro Hirakawa

Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan

Masahiko Ando

Marfan Syndrome Center, The University of Tokyo Hospital, Tokyo, Japan

Masahiro Hayakawa

3Department of Pediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan

Nao Matsuyama

Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan

Shinobu Shimizu

Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan

Kazuto Ueda

Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan

Toshihiko Suzuki

Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan

Sakiko Suzuki

Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan

Ryosuke Miura

Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan

Akemi Katayama

Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan

Masaaki Mizuno

Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan

Yoshiaki Sato

Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan