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

NCT ID: NCT03309514

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-06-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Intracerebral microinjections

Intervention Type: BIOLOGICAL

Stereotactic delivery of cell suspension into basal ganglia structures

Interventions

Intracerebral microinjections

Stereotactic delivery of cell suspension into basal ganglia structures

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroGeneration

INDUSTRY

Sponsor Role: lead

Responsible Party

Michel F. Levesque, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NGN-9076

Identifier Type: -

Identifier Source: org_study_id