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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03309514
• Other study ID #: NGN-9076
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2022
• Source: NeuroGeneration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Biological:
• Intracerebral microinjections
Stereotactic delivery of cell suspension into basal ganglia structures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeuroGeneration

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor UPDRS	UPDRS Motor scale	6 months