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

Phase 1

Withdrawn

• Conditions: Parkinson's Disease
• Interventions: Biological: Intracerebral microinjections

• Registration Number: NCT03309514
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12
• Study Start: 2022-06
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Intracerebral microinjections	-

Primary Outcome Measures

Name	Time	Method
Motor UPDRS	6 months	UPDRS Motor scale