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Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial

Crossref DOI link: https://doi.org/10.1186/s13063-022-06327-4

Published Online: 2022-05-18

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Nam, Jae-Yong

Lee, Tae Yong

Kim, Kwijoo

Chun, Sehwan

Kim, Min Sung

Shin, Jin-Hong

Sung, Jung-Joon

Kim, Byoung Joon

Kim, Byung-Jo

Oh, Ki-Wook

Kim, Kyung Suk

Kim, Seung Hyun
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Text and Data Mining valid from 2022-05-18

Version of Record valid from 2022-05-18
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Article History

Received: 21 November 2021

Accepted: 23 April 2022

First Online: 18 May 2022

Declarations

:

: The clinical trial protocol, informed consent form, the information provided to subjects, and the related source documents will be submitted to the Institutional Review Board (IRB) for review and approval (HYUH: HYUH-2018-09-025, KNAH: 2019AN0209, SMC: SMC 2019-08-122, SNUH: H-1908-150-1058, and PNUH: 02-2019-027). All recruitment-related data must also be approved by the IRB. All participants will provide written informed consent.

: Not applicable. This manuscript does not include any individual data from participants.

: JYN, TYL, KJK, SHC, MSK, and KSK are employees of Corestem Inc. All other authors declare that they have no competing interests.

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