Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease

Bundang CHA Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Idiopathic Parkinson Disease; Primary Parkinsonism

Treatments: Drug: Mesencephalic Neuronal Precursor Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01860794

PBC09-074

Details and patient eligibility

About

The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.

Full description

This study is phase I/II clinical trials which is accessible to those involved in the study and conducted by only Bundang CHA hospital.

The progress of the clinical trails is reported to and evaluated by Data monitoring committee before the enrolment of next human subject.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female patients with idiopathic or primary Parkinson's disease
2. Hoehn and Yare (HY) stage III or IV
3. more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning
4. Patients aged less than 70
5. Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery

Exclusion criteria

1. Atypical or secondary parkinsonism
2. Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30
3. Psychological disorders (illusion, delusion, schizophrenia)
4. Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24
5. Epilepsy
6. Medial history of brain surgery
7. Medical history of other brain diseases
8. Hemorrhagic tendency
9. Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer
10. Experience of participating in clinical trial within 30 days
11. Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls
12. Pregnant or lactating women
13. Patients who are not considered to be eligible to participate in clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Mesencephalic Neuronal Precursor Cells

Other group

Treatment:

Drug: Mesencephalic Neuronal Precursor Cells