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Efficacy and Safety of NestaCell® in Huntington's Disease (STAR)

Primary Purpose

Huntington Disease

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NestaCell®
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring STAR, NestaCell ®

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female; Age from 18 to 55 years; HD diagnostic confidence level (DCL) score of 3 or 4 at enrolment; HD manifestations begin from 4 to 8 years before enrolment; UHDRS Total Functional Capacity (TFC) from 7 to 12, suggesting mild-moderate functional impairment; Body weight at the V -1 from 50 to 90 Kg; CAG repeats from 40 to 50; ICF signature. Exclusion Criteria: Juvenile Huntington's disease, Concomitant epilepsy; Decompensated psychiatric disorders; History of a suicide attempt; Other neurological or musculoskeletal disorders that might interfere with the assessments; Prior use of gene or cell therapy. Confirmed or suspected cancer within the last 1 year (except operated basal cell carcinoma); History of allergy to imaging exams contrast, or bovine origin products; Current or planned use of immunosuppressants; Clinically significant changes in the safety exams, defined as; Serum transaminases (ALT, AST) increased > 2.5 × upper limit of normality (ULN). Absolute neutrophil count in peripheral blood < 3,000 cells/1 mm3. Serum creatinine > 2 × age- and sex-specific ULN. Positive serology for HIV 1 and 2 (Anti-HIV-1,2), HTLV I and II, HBV (HBsAg, Anti-HBc), HCV (anti-HCV-Ab), and FTA-ABS. Amylase, Troponin I, CKmB increased > 2.0 × ULN. Malignancy shown by the Total-Body PET Scan. Glycated hemoglobin > 6.5%. aPTT, TT, platelets > 2.5 x ULN. Pregnancy, lactation, or pregnancy plan; BMI less than 18.5 at enrolment; Participation in a clinical trial within twelve months before inclusion; History of surgical procedures aiming at improving symptoms of Huntington's disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents, or deep brain stimulation. Any medical condition that makes the patient unsuitable for the study or increases the risk of participation at the investigator's discretion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Intravenous NestaCell® administrations

    Arm Description

    Arm 1: Nine intravenous placebo administrations in twelve months.

    Arm 2: Nine intravenous NestaCell® administrations in twelve months.

    Outcomes

    Primary Outcome Measures

    Primary Efficacy Objective
    Proportion of patients who stabilized or decreased the UHDRS-TMS from Visit 0 to Visit 12 in the Nestacell® vs. Placebo groups.

    Secondary Outcome Measures

    Secondary Efficacy Objectives
    Mean variation of the UHDRS-TMS mean variation from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Proportion of patients who stabilized or increased the UHDRS-TFC from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Mean variation of the UHDRS-TFC from Visit 0 to Visit 12 of the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Proportion of patients who stabilized or increased the cUHDRS from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Mean variation of the cUHDRS from Visit 0 to Visit 12 of the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Proportion of patients who stabilized the MRI outcomes: 7.1 white substance, 7.2 gray substance, from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Mean variation of the MRI outcomes: 8.1 white substance, 8.2 gray substance, from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Proportion of patients who stabilized or decreased the NfL blood levels from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Secondary Efficacy Objectives
    Mean variation of the NfL blood levels from Visit 0 to Visit 12 of the groups Nestacell® and Placebo.

    Full Information

    First Posted
    October 5, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Azidus Brasil
    Collaborators
    Cellavita Pesquisa Científica Ltda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06097780
    Brief Title
    Efficacy and Safety of NestaCell® in Huntington's Disease
    Acronym
    STAR
    Official Title
    Phase III Efficacy and Safety of NestaCell® in Moderated Huntington's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 8, 2024 (Anticipated)
    Primary Completion Date
    September 8, 2025 (Anticipated)
    Study Completion Date
    February 9, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azidus Brasil
    Collaborators
    Cellavita Pesquisa Científica Ltda

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Huntington's disease (HD) is a rare neurodegenerative condition caused by increased CAG trinucleotide repeats in the HTT gene, on chromosome 4. The estimated global prevalence is 2.71 cases per 100,000 inhabitants. In Brazil, it is estimated that 13,000 to 19,000 people carry the gene and 65,000 to 95,000 are descendants at risk. HD usually manifests itself in the fourth decade of life with motor, cognitive and behavioral symptoms, such as chorea. This condition profoundly affects quality of life and there is no treatment that can modify its course. Tetrabenazine is the only medication approved to control chorea. A partnership between the Butantan Institute and Cellavita investigates the use of Human Dental Pulp Stem Cells (hDPSCs) to treat HD. NestaCell® was developed, a product based on these cells, which express high levels of BDNF, an important neurotrophic factor for neuronal survival. Preclinical tests showed that NestaCell® is distributed to several organs, including the central nervous system, being well tolerated in toxicological tests in rats. In phase I (SAVE) and phase II (ADORE) clinical trials, NestaCell® was administered to patients with HD. The results indicated a significant improvement in motor scores and functional capacity compared to placebo, demonstrating a clinically significant benefit. NestaCell® also presented a good safety and tolerability profile, with few adverse events related to the product. The results support the conclusion that NestaCell® is safe and well tolerated in HD patients, within the doses tested.
    Detailed Description
    This is a Phase III multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Nestacell® in Huntington's Disease. After signing the Informed Consent Form (ICF) the patients will perform the V-2 and V-1 screening procedures. In the V-2 the site collects personal data and a physician clinically confirms the HD diagnosis. The patient collects blood for CAG repeats and safety exams. Females with childbearing potential perform a urine pregnancy test. In the V-1 the investigator remotely reviews the results of the V-2 exams and authorizes the performance of the V-1 radiological exams (MRI and Total-Body PET Scan) in the radiology center. In the V0, the PI and his team perform the baseline UHDRS and body weight assessments. The patient will be randomized to Nestacell® or placebo. Those weighing 50 to 67.9 kg will receive 100 million cells (or placebo) and those weighing ≥ 68 kg will receive 136 million cells(or placebo) per administration. The doses are based on the V0 weight assessment and will not change throughout the study unless the PI asks for safety reasons (for example, a relevant weight loss). The V1 marks the first investigational product administration. It will happen in sites unrelated to those performing the outcomes evaluation by personnel specially trained to prepare and administer the investigational product. After the females with childbearing potential performe the urine pregnancy test, NestaCell® or placebo will be administered intravenously in three cycles of three-monthly administrations with a monthly interval between cycles (total of 9 administrations). The other administrations happen at visits V2, V3, V5, V6, V7, V9, V10, and V11. To assure blindness, UHDRS and other clinical evaluations will be carried out in the research center [by the principal investigator (PI)] while the administrations will be made in the Center for the Investigational Product Administration (CIPA). The outcome evaluations by the PI and his/her team happen at V4, V8, and V12, one month after the end of each cycle. In the V13, the patients will also be directed to the radiology center to repeat the MRI exam. Each patient participates in the trial for approximately 14 months, two months for screening, and twelve months for investigational product administration and follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Huntington Disease
    Keywords
    STAR, NestaCell ®

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    The trial will evaluate 120 adult patients (male and female) aged 18 to 55 years with Huntington's disease:CAG repeats from 40 to 50; HD diagnostic confidence level (DCL) score of 4;UHDRS Total Functional Capacity (TFC) from 7 to 12, suggesting mild-moderate functional impairment. Each patient participates in the trial for approximately 14 months, two months for screening, and twelve months for investigational product administration and follow-up.
    Masking
    Outcomes Assessor
    Masking Description
    The trial will be two-armed double-blind (participant and investigator's team responsible for outcome assessments).
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Arm 1: Nine intravenous placebo administrations in twelve months.
    Arm Title
    Intravenous NestaCell® administrations
    Arm Type
    Experimental
    Arm Description
    Arm 2: Nine intravenous NestaCell® administrations in twelve months.
    Intervention Type
    Genetic
    Intervention Name(s)
    NestaCell®
    Intervention Description
    Human Dental Pulp Stem Cells (hDPSCs).
    Primary Outcome Measure Information:
    Title
    Primary Efficacy Objective
    Description
    Proportion of patients who stabilized or decreased the UHDRS-TMS from Visit 0 to Visit 12 in the Nestacell® vs. Placebo groups.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Secondary Efficacy Objectives
    Description
    Mean variation of the UHDRS-TMS mean variation from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Proportion of patients who stabilized or increased the UHDRS-TFC from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Mean variation of the UHDRS-TFC from Visit 0 to Visit 12 of the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Proportion of patients who stabilized or increased the cUHDRS from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Mean variation of the cUHDRS from Visit 0 to Visit 12 of the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Proportion of patients who stabilized the MRI outcomes: 7.1 white substance, 7.2 gray substance, from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Mean variation of the MRI outcomes: 8.1 white substance, 8.2 gray substance, from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Proportion of patients who stabilized or decreased the NfL blood levels from Visit 0 to Visit 12 in the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Title
    Secondary Efficacy Objectives
    Description
    Mean variation of the NfL blood levels from Visit 0 to Visit 12 of the groups Nestacell® and Placebo.
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Secondary Safety Objective
    Description
    Occurrence, severity and cause of adverse events related to the study drug
    Time Frame
    1 year
    Title
    Exploratory objectives
    Description
    Blood concentration of nestin, IL-6, IL-17, TNFα, IFN-γ, C-reactive protein, BDNF, PT, aPTT, and D-dimer and the saliva concentration of BDNF and huntingtin before and 24 h after the NestaCell® administration at V1 and in a subset of 20-30 HD patients.
    Time Frame
    1 year
    Title
    Exploratory objectives
    Description
    Blood concentration of nestin, IL-6, IL-17, TNFα, IFN-γ, C-reactive protein, BDNF, PT, aPTT, and D-dimer and the saliva concentration of BDNF and huntingtin before and 24 h after the NestaCell® administration at V9 in a subset of 20-30 HD patients.
    Time Frame
    Up to 9 months
    Title
    Exploratory objectives
    Description
    Evolution between V1 and V9 of the blood concentration of nestin, IL-6, IL-17, TNFα, IFN-γ, C-reactive protein, BDNF, PT, aPTT, and D-dimer and the saliva concentration of BDNF and huntingtin before the NestaCell® administration in a subset of 20-30 HD patients
    Time Frame
    Up to 9 months
    Title
    Exploratory objectives
    Description
    Evolution between V1 and V9 of the blood concentration of nestin, IL-6, IL-17, TNFα, IFN-γ, C-reactive protein, BDNF, PT, aPTT, and D-dimer and the saliva concentration of BDNF and huntingtin 24 hours after the NestaCell® administration in a subset of 20-30 HD patients.
    Time Frame
    Up to 9 months
    Title
    Exploratory objectives
    Description
    Measure of the relative amount of study participants who experienced changes in hair color during the course of the study.Nestacell® and placebo groups.
    Time Frame
    1 year
    Title
    Exploratory objectives
    Description
    Measure of the relative number of study participants who experienced hair growth.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female; Age from 18 to 55 years; HD diagnostic confidence level (DCL) score of 3 or 4 at enrolment; HD manifestations begin from 4 to 8 years before enrolment; UHDRS Total Functional Capacity (TFC) from 7 to 12, suggesting mild-moderate functional impairment; Body weight at the V -1 from 50 to 90 Kg; CAG repeats from 40 to 50; ICF signature. Exclusion Criteria: Juvenile Huntington's disease, Concomitant epilepsy; Decompensated psychiatric disorders; History of a suicide attempt; Other neurological or musculoskeletal disorders that might interfere with the assessments; Prior use of gene or cell therapy. Confirmed or suspected cancer within the last 1 year (except operated basal cell carcinoma); History of allergy to imaging exams contrast, or bovine origin products; Current or planned use of immunosuppressants; Clinically significant changes in the safety exams, defined as; Serum transaminases (ALT, AST) increased > 2.5 × upper limit of normality (ULN). Absolute neutrophil count in peripheral blood < 3,000 cells/1 mm3. Serum creatinine > 2 × age- and sex-specific ULN. Positive serology for HIV 1 and 2 (Anti-HIV-1,2), HTLV I and II, HBV (HBsAg, Anti-HBc), HCV (anti-HCV-Ab), and FTA-ABS. Amylase, Troponin I, CKmB increased > 2.0 × ULN. Malignancy shown by the Total-Body PET Scan. Glycated hemoglobin > 6.5%. aPTT, TT, platelets > 2.5 x ULN. Pregnancy, lactation, or pregnancy plan; BMI less than 18.5 at enrolment; Participation in a clinical trial within twelve months before inclusion; History of surgical procedures aiming at improving symptoms of Huntington's disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents, or deep brain stimulation. Any medical condition that makes the patient unsuitable for the study or increases the risk of participation at the investigator's discretion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luciana Ferrara, Doctor
    Phone
    + 55 19 981428814
    Email
    luciana.ferrara@azidusbrasil.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luciana Ferrara, Doctor
    Organizational Affiliation
    Azidus Brasil
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    After the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
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    Efficacy and Safety of NestaCell® in Huntington's Disease

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