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Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Intracerebral microinjections
Sponsored by
NeuroGeneration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to give informed consent prior to study
  2. Male or Female with Diagnostic Criteria of Parkinson's disease
  3. Age 35 to 85 years old
  4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
  5. Hoehn and Yahr Stage III or IV

  6. Parkinson's disease observed in the absence of:

    • Oculomotor palsy
    • Cerebellar sign
    • Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
    • Pyramidal sign
    • Amyotrophy
  7. Good general health or stable medical condition well controlled, without contraindications to anesthesia

Exclusion Criteria:

  1. Patients with severe dementia and brain atrophy on MRI
  2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
  3. Patients older than 85 or younger than 35
  4. Patients who withhold informed consent
  5. Patients with a history of alcohol or drug abuse
  6. Sexually active women of childbearing potential without adequate form of birth control
  7. Evidence of abnormal coagulation or anticoagulant therapy
  8. Pregnancy or lactation
  9. History of seizure disorders or current use of antiepileptic medication
  10. Severe cognitive impairment
  11. Clinically significant laboratory abnormality

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Motor UPDRS
    UPDRS Motor scale

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2017
    Last Updated
    April 4, 2022
    Sponsor
    NeuroGeneration
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03309514
    Brief Title
    Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease
    Official Title
    Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Insufficient funding
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    NeuroGeneration

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Intracerebral microinjections
    Intervention Description
    Stereotactic delivery of cell suspension into basal ganglia structures
    Primary Outcome Measure Information:
    Title
    Motor UPDRS
    Description
    UPDRS Motor scale
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to give informed consent prior to study Male or Female with Diagnostic Criteria of Parkinson's disease Age 35 to 85 years old Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease Hoehn and Yahr Stage III or IV Parkinson's disease observed in the absence of: Oculomotor palsy Cerebellar sign Orthostatic hypotension (drop greater than 20mmHg in mean pressure) Pyramidal sign Amyotrophy Good general health or stable medical condition well controlled, without contraindications to anesthesia Exclusion Criteria: Patients with severe dementia and brain atrophy on MRI Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV Patients older than 85 or younger than 35 Patients who withhold informed consent Patients with a history of alcohol or drug abuse Sexually active women of childbearing potential without adequate form of birth control Evidence of abnormal coagulation or anticoagulant therapy Pregnancy or lactation History of seizure disorders or current use of antiepileptic medication Severe cognitive impairment Clinically significant laboratory abnormality

    12. IPD Sharing Statement

    Learn more about this trial

    Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease

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