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Authors
Fernandes, Joyce Macedo Sanches
Pagani, Eduardo https://orcid.org/0000-0002-6366-0829
Wenceslau, Cristiane Valverde
Ynoue, Leandro Hideki
Ferrara, Luciana
Kerkis, Irina
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03252535 at ClinicalTrials.govDocuments that mention this clinical trial
Phase II trial of intravenous human dental pulp stem cell therapy for Huntington’s disease: a randomized, double-blind, placebo-controlled study
https://doi.org/10.1186/s13287-025-04557-2
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Article History
Received: 31 March 2025
Accepted: 18 July 2025
First Online: 6 August 2025
Declarations
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: The study protocol “Avaliação da Dose-Resposta do Produto Investigacional Cellavita HD após Aplicação Intravenosa em Participantes com Doença de Huntington” was first approved by the ethical committee of Faculdade de Medicina de Jundiai (Approval number: 52375916.1.0000.5412) on 4, February 2016, conformed to the ICH-E6 guidelines. The last amendment was approved on December 26, 2019. All participants provided written informed consent before recruitment. This study was registered on clinicaltrials.gov (Identifier: NCT03252535). 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.
