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WithdrawnNCT03309514Updated Apr 12, 2022

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

A Phase 1/2 interventional study of Intracerebral microinjections in Parkinson's Disease, sponsored by NeuroGeneration. Withdrawn. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by NeuroGeneration · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Insufficient funding
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
35 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson's Disease

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03

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment

    Biological: Intracerebral microinjections

Interventions

  • BiologicalIntracerebral microinjections

    Stereotactic delivery of cell suspension into basal ganglia structures

05

What researchers measure

Primary outcomes

  1. Motor UPDRS

    UPDRS Motor scale

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03309514
Lead sponsor
NeuroGeneration
Responsible party
Michel F. Levesque, MD (Principal Investigator, NeuroGeneration) — Principal investigator
First posted
Oct 13, 2017
Start date
Jun 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Apr 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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