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

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ClinicalTrials.gov Identifier: NCT03309514
Recruitment Status : Withdrawn (Insufficient funding)
First Posted : October 13, 2017
Last Update Posted : April 12, 2022
Information provided by (Responsible Party):
Michel F. Levesque, MD, NeuroGeneration

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Biological: Intracerebral microinjections Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Biological: Intracerebral microinjections
Stereotactic delivery of cell suspension into basal ganglia structures

Primary Outcome Measures :
  1. Motor UPDRS [ Time Frame: 6 months ]
    UPDRS Motor scale

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Michel F. Levesque, MD, Principal Investigator, NeuroGeneration
ClinicalTrials.gov Identifier: NCT03309514    
Other Study ID Numbers: NGN-9076
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases