Cellavita HD (stem-cell therapy for Huntington's Disease) / Cellavita Scientific Research - LARVOL DELTA

Phase II trial of intravenous human dental pulp stem cell therapy for Huntington's disease: a randomized, double-blind, placebo-controlled study. (PubMed, Stem Cell Res Ther) - P2 | "NestaCell® was well tolerated and showed statistically significant improvements in motor and functional outcomes in HD patients. While MRI trends suggest a potential neuroprotective effect, further investigation is warranted. These findings support the advancement to a Phase III trial to confirm efficacy and long-term safety in a larger cohort."

Clinical • Journal • P2 data • CNS Disorders • Huntington's Disease • Inflammation • Movement Disorders

Huntington's Disease Drug Development: A Phase 3 Pipeline Analysis. (PubMed, Pharmaceuticals (Basel)) - "Of the nine clinical trials that met these criteria, eight involved the following drugs: metformin, dextromethorphan/quinidine, deutetrabenazine, valbenazine, Cellavita HD, pridopidine, SAGE-718, and RO7234292 (RG6042). Of these drug treatments, four are already FDA approved. This systematic review provides a resource that summarizes the present therapies for treating this devastating condition that are currently in phase III clinical trials in the United States."

Journal • P3 data • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Huntington's Disease • Movement Disorders • Psychiatry

SAVE-DH: Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's Disease (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Azidus Brasil | Trial primary completion date: Oct 2022 ➔ Dec 2022

Trial primary completion date • Genetic Disorders • Huntington's Disease • Movement Disorders • CD4 • CD8 • IL10 • IL6 • TNFA

ADORE-EXT: Clinical Extension Study for Safety and Efficacy Evaluation of Cellavita-HD Administration in Huntington's Patients. (clinicaltrials.gov) - P2/3 | N=35 | Active, not recruiting | Sponsor: Azidus Brasil | Trial completion date: Apr 2022 ➔ Dec 2022 | Trial primary completion date: Jan 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Genetic Disorders • Huntington's Disease • Movement Disorders

ADORE-DH: Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease (clinicaltrials.gov) - P2; N=35; Completed; Sponsor: Azidus Brasil; Active, not recruiting ➔ Completed; Trial completion date: Apr 2022 ➔ Apr 2021; Trial primary completion date: Jan 2022 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Huntington's Disease • Movement Disorders

ADORE-EXT: Clinical Extension Study for Safety and Efficacy Evaluation of Cellavita-HD Administration in Huntington's Patients. (clinicaltrials.gov) - P2/3; N=35; Active, not recruiting; Sponsor: Azidus Brasil; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Genetic Disorders • Huntington's Disease • Movement Disorders • MRI

ADORE-EXT: Clinical Extension Study for Safety and Efficacy Evaluation of Cellavita-HD Administration in Huntington's Patients. (clinicaltrials.gov) - P2/3; N=35; Not yet recruiting; Sponsor: Azidus Brasil

Clinical • New P2/3 trial

ADORE-DH: Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease (clinicaltrials.gov) - P2; N=35; Active, not recruiting; Sponsor: Azidus Brasil; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2021 ➔ Apr 2022; Trial primary completion date: Apr 2020 ➔ Jan 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

ADORE-DH: Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease (clinicaltrials.gov) - P2; N=35; Recruiting; Sponsor: Azidus Brasil; Trial completion date: Sep 2020 ➔ Jun 2021

Clinical • Trial completion date

SAVE-DH: Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's Disease (clinicaltrials.gov) - P1; N=6; Active, not recruiting; Sponsor: Azidus Brasil; Trial completion date: Aug 2023 ➔ Dec 2023; Trial primary completion date: Jan 2023 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date