Huntington's Disease Treatment With Dental Pulp Stem Cells (DPSCs) Moves to Phase III Clinical Trials

ABSTRACT

Efficacy and Safety of NestaCell® in Huntington's Disease
ClinicalTrials.gov Identifier: NCT06097780

Study information
Sponsor: Azidus Brasil Pesquisa Ltda.
Investigational Product: NestaCell® (Human Dental Pulp Stem Cells)
Study Phase: Phase III
Study Type: Interventional (Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled) Study Population: Adults diagnosed with Huntington's disease.

BACKGROUND:Huntington's disease is a progressive, inherited neurodegenerative disorder characterized by motor dysfunction, cognitive decline, and psychiatric symptoms. Current therapies help manage symptoms but do not slow or reverse disease progression. Dental pulp stem cells (DPSCs) possess neuroprotective, immunomodulatory, and regenerative properties that may help preserve neuronal function, reduce neuroinflammation, and improve neurological outcomes in patients with Huntington's disease.

METHODS:This multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial evaluates NestaCell®, an investigational therapy derived from human dental pulp stem cells (hDPSCs). Participants are randomly assigned to receive either intravenous NestaCell® or placebo and are monitored throughout the study for neurological function, disease progression, treatment safety, and quality of life using standardized clinical assessments.

RESULTS:The study is currently ongoing, and final clinical efficacy results have not yet been reported. Researchers aim to determine whether NestaCell® can safely slow disease progression, improve neurological function, and enhance quality of life in patients with Huntington's disease compared with placebo.

CONCLUSIONS:This Phase III clinical trial investigates whether dental pulp stem cells can provide a safe and effective regenerative treatment for Huntington's disease. If successful, NestaCell® could represent a significant advancement in the development of stem cell-based therapies for neurodegenerative disorders.

ClinicalTrials.gov Identifier: NCT06097780
Investigational Product: NestaCell®
Sponsor: Azidus Brasil Pesquisa Ltda.