The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

Summary

The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.

Timeline

Start

2020-03-04

Primary completion

2021-09-29

Completion

2022-12-12

Publications

• Sato Y, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Ando M, Tsuda K, Iwata O, Muramatsu Y, Kidokoro H, Hirakawa A, Hayakawa M; SHEILD team. Safety and tolerability of a Muse cell-based product in neonatal hypoxic-ischemic encephalopathy with therapeutic hypothermia (SHIELD trial). Stem Cells Transl Med. 2024 Nov 12;13(11):1053-1066. doi: 10.1093/stcltm/szae071.
• Matsuyama N, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Katayama A, Ando M, Mizuno M, Hirakawa A, Hayakawa M, Sato Y. 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. BMJ Open. 2022 Apr 26;12(4):e057073. doi: 10.1136/bmjopen-2021-057073.

Drugs

Indications