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Article History

Received: 3 April 2025

Accepted: 23 September 2025

First Online: 4 November 2025

Declarations

:

: The study protocol “ Estudo First in Human para Avaliação da Segurança do Produto Investigacional Cellavita HD após Aplicação Intravenosa em Participantes com Doença de Huntington ” was first approved by the Ethics Committee of Faculdade de Medicina de Jundiai (Approval number: 51005115.9.0000.5412) on December 11, 2015, conformed to the ICH-GCP guidelines. The last amendment was approved on November 7, 2019. All participants provided written informed consent before recruitment. This study was registered on ClinicalTrials.gov. Gov (Identifier: NCT02728115).

: The investigational product evaluated in this study was originally developed under the name Cellavita HD. In March 2020, it was registered under the trademark NestaCell®. Both names refer to the same cell-based product. In this manuscript, the current designation NestaCell® is used consistently; however, the original name Cellavita HD is retained when citing regulatory documents—such as the ethics committee approval—where that designation was originally employed.

: Written informed consent was obtained from all patients, all authors, and the Sponsor for the publication of this report.

: EP & CVW are employees of the study sponsor. IK & CVW are listed as inventors on the NestaCell® patent and hold associated commercial rights. JMSF, LF & LHY declare no competing interests.