Title

Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease
Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
  • Phase

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Status

    Withdrawn
  • Study Participants

    0
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.
Study Started
Jun 30
2022
Anticipated
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Jun 30
2024
Anticipated
Last Update
Apr 12
2022

Biological Intracerebral microinjections

Stereotactic delivery of cell suspension into basal ganglia structures

Treatment Experimental

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
No Results Posted