<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03252535</url>
  </required_header>
  <id_info>
    <org_study_id>ADORE-DH</org_study_id>
    <secondary_id>52375916.1.0000.5412</secondary_id>
    <nct_id>NCT03252535</nct_id>
  </id_info>
  <brief_title>Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease</brief_title>
  <acronym>ADORE-DH</acronym>
  <official_title>Dose-Response Evaluation of the Investigational Product Cellavita HD After Intravenous Administration in Patients With Huntington's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azidus Brasil</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cellavita Pesquisa Científica Ltda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azidus Brasil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase&#xD;
      II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test&#xD;
      doses of Cellavita HD product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II dose-response study in which participants with HD will receive three&#xD;
      intravenous injections of the investigational product or placebo (one every month for three&#xD;
      months) a total of three cycles. The subjects will be randomized in 2: 2: 1 ratio for the&#xD;
      groups G1: lower dose (1x10^6 cells/weight range), G2: higher dose (2x10^6 cells/weight&#xD;
      range) or G3: placebo. To identify the dose of the product that will provide the best&#xD;
      clinical response, motor assessment will be performed with UHDRS scale and improvement will&#xD;
      be evaluated by correlating before and after treatment scores. Additionally, also will be&#xD;
      performed the combined score through the cUHDRS. Secondary evidences of efficacy will be&#xD;
      evaluated through the data of functional state, total functional capacity, functional&#xD;
      independence, psychiatric symptoms and cognition from UHDRS scale. Additionally, related data&#xD;
      to clinical worsening, change of Body Mass Index (BMI), risk of suicide attempt and&#xD;
      neurological image improvement will be evaluated. Safety evaluation will included the&#xD;
      incidence and classification of the adverse events experienced by the subjects during the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 23, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The study drugs will be provided in identical packages to maintain the study masking. Neither the Investigator nor the study team will know which drug the subject is receiving. In addition, the external outcome evaluator will receive the results in a codified manner (concealed).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effective Dose</measure>
    <time_frame>monthly for fourteen months</time_frame>
    <description>Consists of identifying the dose of the product Cellavita HD providing the best clinical response. It will be verified through the baseline Unified Huntington's Disease Rating Scale (UHDRS) score from the end of treatment (motor, cognitive, behavioral, functional capacity and independence domains). Additionally, also will be performed the combined score through the cUHDRS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical neurological worsening over the treatment</measure>
    <time_frame>monthly for fourteen months</time_frame>
    <description>The clinical neurological worsening over the treatment will be evaluated by specific UHDRS domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI assessment</measure>
    <time_frame>monthly for fourteen months</time_frame>
    <description>The BMI (Body Mass Index) will be assessed through the BMI profiles obtained during the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of suicidal ideation</measure>
    <time_frame>monthly for fourteen months</time_frame>
    <description>Will be evaluated by suicidal domain from Hamilton Depression Scale (HAM-D). The classificatory punctuation may correspond to mild depression (score: 8 to 13), moderate depression (score: 19 - 22) and severe depression (score: &gt; 23).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CNS assessment</measure>
    <time_frame>baseline and one year later</time_frame>
    <description>Will be evaluated by statistical comparison of the CNS assessment through magnetic resonance image at cortical thickness measurements, volumes of different brain structures, especially the basal ganglia, with special attention to caudate and metabolic changes identified in proton spectroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Interview Based impression of Severity (CIBIS)</measure>
    <time_frame>monthly for fourteen months</time_frame>
    <description>A general global assessment tool for disease severity that associates the impression of a medical interviewer with a patient / caregiver opinion. After observing the data obtained during the clinical interview, the interviewer records the appropriate score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety administration of Cellavita HD product</measure>
    <time_frame>monthly for fourteen months</time_frame>
    <description>Will be carefully evaluated from the periodical assessments including clinical, laboratory, and imaging exams, so that any change is properly recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Prognosis of Huntington Disease</measure>
    <time_frame>baseline and one year later</time_frame>
    <description>This parameter will be evaluated by statistical comparison of NF-L (biological marker) results observed at baseline period and other analysed times. The results will be correlated to UHRDS scores.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Huntington Disease</condition>
  <arm_group>
    <arm_group_label>Cellavita HD Lower Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cellavita HD Higher Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants randomized to this group will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cellavita HD lower dose</intervention_name>
    <description>The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).</description>
    <arm_group_label>Cellavita HD Lower Dose</arm_group_label>
    <other_name>cellular therapy, mesenchymal stem cells</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cellavita HD higher dose</intervention_name>
    <description>The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).</description>
    <arm_group_label>Cellavita HD Higher Dose</arm_group_label>
    <other_name>cellular therapy, mesenchymal stem cells</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).</description>
    <arm_group_label>Placebo Group</arm_group_label>
    <other_name>physiological solution without cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provide a written, signed and dated Informed Consent Form;&#xD;
&#xD;
          2. Male and female subjects aged ≥ 21 and ≤ 65 years;&#xD;
&#xD;
          3. Have a confirmatory diagnosis report (PCR) of Huntington's disease with a number of&#xD;
             CAG repeats in chromosome 4 higher than or equal to 40, and lower than or equal to 50&#xD;
             (if the subject did not perform the exam and/or if he/she does not have an available&#xD;
             result for this exam, a new exam must be performed);&#xD;
&#xD;
          4. A score of 5 points or higher for the motor evaluation of the UHDRS scale (Unified&#xD;
             Huntington's Disease Rating Scale) at enrollment;&#xD;
&#xD;
          5. Score of 8 to 11 points for the functional capacity of the UHDRS scale at enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject who participated in clinical trials protocols within the last twelve (12)&#xD;
             months (Resolution CNS 251, August 7, 1997, item III, subitem J), unless, at the&#xD;
             investigator's opinion, the subject would have a direct benefit from it;&#xD;
&#xD;
          2. Diagnosis of juvenile Huntington's disease;&#xD;
&#xD;
          3. Diagnosis of epilepsy;&#xD;
&#xD;
          4. Diagnosis of major cognitive disorder;&#xD;
&#xD;
          5. Active decompensated psychiatric illness;&#xD;
&#xD;
          6. Current or prior history of neoplasm;&#xD;
&#xD;
          7. Current history of gastrointestinal, hepatic, renal, endocrine, pulmonary,&#xD;
             hematological, immunological, metabolic pathology or severe uncontrolled&#xD;
             cardiovascular diseases;&#xD;
&#xD;
          8. Diagnosis of any active infection, whether viral, bacterial, fungal or caused by&#xD;
             another pathogen;&#xD;
&#xD;
          9. Subject with contraindication to the exams performed in this study, for example, with&#xD;
             pacemaker or surgical clip; Alcohol and drugs abuse (previously diagnosed according to&#xD;
             the Diagnostic and Statistical Manual of Mental Disorders - DSM V criteria);&#xD;
&#xD;
         10. Use of illegal drugs;&#xD;
&#xD;
         11. Tabagism;&#xD;
&#xD;
         12. Smoker or quit smoking for less than 6 months;&#xD;
&#xD;
         13. Positive result in one of the serum tests: HIV 1 and 2 (Anti-HIV-1,2), HTLV I and II,&#xD;
             HBV (HBsAg, Anti-HBc), HCV (anti-HCV-Ab) and FTA-ABS (Treponema pallidum);&#xD;
&#xD;
         14. History of drug allergy, including to contrast agents used in imaging tests or&#xD;
             bovine-derived products;&#xD;
&#xD;
         15. Using or expects to use immunosuppressant drugs or forbidden drugs (item 5.3) during&#xD;
             the first three months after the first administration of the investigational product;&#xD;
&#xD;
         16. Any clinical change that the investigator considers a risk to subject's enrollment in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce Macedo da Silva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azidus Brasil Scientific Research and Development Ltda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.</name>
      <address>
        <city>Valinhos</city>
        <state>São Paulo</state>
        <zip>13271-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Aleynik A, Gernavage KM, Mourad YSh, Sherman LS, Liu K, Gubenko YA, Rameshwar P. Stem cell delivery of therapies for brain disorders. Clin Transl Med. 2014 Jul 19;3:24. doi: 10.1186/2001-1326-3-24. eCollection 2014.</citation>
    <PMID>25097727</PMID>
  </reference>
  <reference>
    <citation>de Almeida FM, Marques SA, Ramalho Bdos S, Rodrigues RF, Cadilhe DV, Furtado D, Kerkis I, Pereira LV, Rehen SK, Martinez AM. Human dental pulp cells: a new source of cell therapy in a mouse model of compressive spinal cord injury. J Neurotrauma. 2011 Sep;28(9):1939-49. doi: 10.1089/neu.2010.1317. Epub 2011 Aug 8.</citation>
    <PMID>21609310</PMID>
  </reference>
  <reference>
    <citation>Barker RA, Mason SL, Harrower TP, Swain RA, Ho AK, Sahakian BJ, Mathur R, Elneil S, Thornton S, Hurrelbrink C, Armstrong RJ, Tyers P, Smith E, Carpenter A, Piccini P, Tai YF, Brooks DJ, Pavese N, Watts C, Pickard JD, Rosser AE, Dunnett SB; NEST-UK collaboration. The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):657-65. doi: 10.1136/jnnp-2012-302441. Epub 2013 Jan 23.</citation>
    <PMID>23345280</PMID>
  </reference>
  <reference>
    <citation>Bonelli RM, Wenning GK. Pharmacological management of Huntington's disease: an evidence-based review. Curr Pharm Des. 2006;12(21):2701-20. doi: 10.2174/138161206777698693.</citation>
    <PMID>16842168</PMID>
  </reference>
  <reference>
    <citation>de Souza PV, Alves FB, Costa Ayub CL, de Miranda Soares MA, Gomes JR. Human immature dental pulp stem cells (hIDPSCs), their application to cell therapy and bioengineering: an analysis by systematic revision of the last decade of literature. Anat Rec (Hoboken). 2013 Dec;296(12):1923-8. doi: 10.1002/ar.22808. Epub 2013 Oct 15.</citation>
    <PMID>24130093</PMID>
  </reference>
  <reference>
    <citation>Fink KD, Deng P, Torrest A, Stewart H, Pollock K, Gruenloh W, Annett G, Tempkin T, Wheelock V, Nolta JA. Developing stem cell therapies for juvenile and adult-onset Huntington's disease. Regen Med. 2015;10(5):623-46. doi: 10.2217/rme.15.25.</citation>
    <PMID>26237705</PMID>
  </reference>
  <reference>
    <citation>Kerkis I, Caplan AI. Stem cells in dental pulp of deciduous teeth. Tissue Eng Part B Rev. 2012 Apr;18(2):129-38. doi: 10.1089/ten.TEB.2011.0327. Epub 2011 Dec 28.</citation>
    <PMID>22032258</PMID>
  </reference>
  <reference>
    <citation>Ross CA, Aylward EH, Wild EJ, Langbehn DR, Long JD, Warner JH, Scahill RI, Leavitt BR, Stout JC, Paulsen JS, Reilmann R, Unschuld PG, Wexler A, Margolis RL, Tabrizi SJ. Huntington disease: natural history, biomarkers and prospects for therapeutics. Nat Rev Neurol. 2014 Apr;10(4):204-16. doi: 10.1038/nrneurol.2014.24. Epub 2014 Mar 11.</citation>
    <PMID>24614516</PMID>
  </reference>
  <reference>
    <citation>Kaplan A, Stockwell BR. Therapeutic approaches to preventing cell death in Huntington disease. Prog Neurobiol. 2012 Dec;99(3):262-80. doi: 10.1016/j.pneurobio.2012.08.004. Epub 2012 Aug 28.</citation>
    <PMID>22967354</PMID>
  </reference>
  <reference>
    <citation>Weiss A, Trager U, Wild EJ, Grueninger S, Farmer R, Landles C, Scahill RI, Lahiri N, Haider S, Macdonald D, Frost C, Bates GP, Bilbe G, Kuhn R, Andre R, Tabrizi SJ. Mutant huntingtin fragmentation in immune cells tracks Huntington's disease progression. J Clin Invest. 2012 Oct;122(10):3731-6. doi: 10.1172/JCI64565. Epub 2012 Sep 17.</citation>
    <PMID>22996692</PMID>
  </reference>
  <reference>
    <citation>Langbehn DR, Brinkman RR, Falush D, Paulsen JS, Hayden MR; International Huntington's Disease Collaborative Group. A new model for prediction of the age of onset and penetrance for Huntington's disease based on CAG length. Clin Genet. 2004 Apr;65(4):267-77. doi: 10.1111/j.1399-0004.2004.00241.x. Erratum In: Clin Genet. 2004 Jul;66(1):81.</citation>
    <PMID>15025718</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Huntington disease</keyword>
  <keyword>Stem cell therapy</keyword>
  <keyword>Dental pulp stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Huntington Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252535
org study id: ADORE-DH
secondary id: 52375916.1.0000.5412
nct id: NCT03252535
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase
      II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test
      doses of Cellavita HD product.
This is a phase II dose-response study in which participants with HD will receive three
      intravenous injections of the investigational product or placebo (one every month for three
      months) a total of three cycles. The subjects will be randomized in 2: 2: 1 ratio for the
      groups G1: lower dose (1x10^6 cells/weight range), G2: higher dose (2x10^6 cells/weight
      range) or G3: placebo. To identify the dose of the product that will provide the best
      clinical response, motor assessment will be performed with UHDRS scale and improvement will
      be evaluated by correlating before and after treatment scores. Additionally, also will be
      performed the combined score through the cUHDRS. Secondary evidences of efficacy will be
      evaluated through the data of functional state, total functional capacity, functional
      independence, psychiatric symptoms and cognition from UHDRS scale. Additionally, related data
      to clinical worsening, change of Body Mass Index (BMI), risk of suicide attempt and
      neurological image improvement will be evaluated. Safety evaluation will included the
      incidence and classification of the adverse events experienced by the subjects during the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The study drugs will be provided in identical packages to maintain the study masking. Neither the Investigator nor the study team will know which drug the subject is receiving. In addition, the external outcome evaluator will receive the results in a codified manner (concealed).
measure: Effective Dose
time frame: monthly for fourteen months
description: Consists of identifying the dose of the product Cellavita HD providing the best clinical response. It will be verified through the baseline Unified Huntington's Disease Rating Scale (UHDRS) score from the end of treatment (motor, cognitive, behavioral, functional capacity and independence domains). Additionally, also will be performed the combined score through the cUHDRS.
measure: Clinical neurological worsening over the treatment
time frame: monthly for fourteen months
description: The clinical neurological worsening over the treatment will be evaluated by specific UHDRS domain.
measure: BMI assessment
time frame: monthly for fourteen months
description: The BMI (Body Mass Index) will be assessed through the BMI profiles obtained during the treatment.
measure: Risk of suicidal ideation
time frame: monthly for fourteen months
description: Will be evaluated by suicidal domain from Hamilton Depression Scale (HAM-D). The classificatory punctuation may correspond to mild depression (score: 8 to 13), moderate depression (score: 19 - 22) and severe depression (score: > 23).
measure: CNS assessment
time frame: baseline and one year later
description: Will be evaluated by statistical comparison of the CNS assessment through magnetic resonance image at cortical thickness measurements, volumes of different brain structures, especially the basal ganglia, with special attention to caudate and metabolic changes identified in proton spectroscopy.
measure: Clinical Interview Based impression of Severity (CIBIS)
time frame: monthly for fourteen months
description: A general global assessment tool for disease severity that associates the impression of a medical interviewer with a patient / caregiver opinion. After observing the data obtained during the clinical interview, the interviewer records the appropriate score.
measure: Safety administration of Cellavita HD product
time frame: monthly for fourteen months
description: Will be carefully evaluated from the periodical assessments including clinical, laboratory, and imaging exams, so that any change is properly recorded.
measure: Prognosis of Huntington Disease
time frame: baseline and one year later
description: This parameter will be evaluated by statistical comparison of NF-L (biological marker) results observed at baseline period and other analysed times. The results will be correlated to UHRDS scores.
arm group label: Cellavita HD Lower Dose
arm group type: Experimental
description: The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
arm group label: Cellavita HD Higher Dose
arm group type: Experimental
description: The participants randomized to this group will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
arm group label: Placebo Group
arm group type: Placebo Comparator
description: The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
intervention type: Biological
intervention name: Cellavita HD lower dose
description: The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
arm group label: Cellavita HD Lower Dose
other name: cellular therapy, mesenchymal stem cells
intervention type: Biological
intervention name: Cellavita HD higher dose
description: The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
arm group label: Cellavita HD Higher Dose
other name: cellular therapy, mesenchymal stem cells
intervention type: Other
intervention name: Placebo
description: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
arm group label: Placebo Group
other name: physiological solution without cells
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Joyce Macedo da Silva, MD
role: Principal Investigator
affiliation: Azidus Brasil Scientific Research and Development Ltda
facility: 
country: Brazil
citation: Aleynik A, Gernavage KM, Mourad YSh, Sherman LS, Liu K, Gubenko YA, Rameshwar P. Stem cell delivery of therapies for brain disorders. Clin Transl Med. 2014 Jul 19;3:24. doi: 10.1186/2001-1326-3-24. eCollection 2014.
PMID: 25097727
citation: de Almeida FM, Marques SA, Ramalho Bdos S, Rodrigues RF, Cadilhe DV, Furtado D, Kerkis I, Pereira LV, Rehen SK, Martinez AM. Human dental pulp cells: a new source of cell therapy in a mouse model of compressive spinal cord injury. J Neurotrauma. 2011 Sep;28(9):1939-49. doi: 10.1089/neu.2010.1317. Epub 2011 Aug 8.
PMID: 21609310
citation: Barker RA, Mason SL, Harrower TP, Swain RA, Ho AK, Sahakian BJ, Mathur R, Elneil S, Thornton S, Hurrelbrink C, Armstrong RJ, Tyers P, Smith E, Carpenter A, Piccini P, Tai YF, Brooks DJ, Pavese N, Watts C, Pickard JD, Rosser AE, Dunnett SB; NEST-UK collaboration. The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):657-65. doi: 10.1136/jnnp-2012-302441. Epub 2013 Jan 23.
PMID: 23345280
citation: Bonelli RM, Wenning GK. Pharmacological management of Huntington's disease: an evidence-based review. Curr Pharm Des. 2006;12(21):2701-20. doi: 10.2174/138161206777698693.
PMID: 16842168
citation: de Souza PV, Alves FB, Costa Ayub CL, de Miranda Soares MA, Gomes JR. Human immature dental pulp stem cells (hIDPSCs), their application to cell therapy and bioengineering: an analysis by systematic revision of the last decade of literature. Anat Rec (Hoboken). 2013 Dec;296(12):1923-8. doi: 10.1002/ar.22808. Epub 2013 Oct 15.
PMID: 24130093
citation: Fink KD, Deng P, Torrest A, Stewart H, Pollock K, Gruenloh W, Annett G, Tempkin T, Wheelock V, Nolta JA. Developing stem cell therapies for juvenile and adult-onset Huntington's disease. Regen Med. 2015;10(5):623-46. doi: 10.2217/rme.15.25.
PMID: 26237705
citation: Kerkis I, Caplan AI. Stem cells in dental pulp of deciduous teeth. Tissue Eng Part B Rev. 2012 Apr;18(2):129-38. doi: 10.1089/ten.TEB.2011.0327. Epub 2011 Dec 28.
PMID: 22032258
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responsible party type: Sponsor
mesh term: Huntington Disease
sharing ipd: Undecided
ipd description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.