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

NCT03309514 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: NGN-9076
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Motor UPDRS

  UPDRS Motor scale

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Biological: Intracerebral microinjections

Interventions

Intracerebral microinjections BIOLOGICAL

Stereotactic delivery of cell suspension into basal ganglia structures

Treatment

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroGeneration: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 13, 2017
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: April 12, 2022

Record last verified: 2022-04