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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease

Conditions
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Idiopathic Parkinson Disease, Primary Parkinsonism

Intervention / Treatment
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* Drug: Mesencephalic Neuronal Precursor Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with idiopathic or primary Parkinson's disease Hoehn and Yare (HY) stage III or IV more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning Patients aged less than 70 Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery Exclusion Criteria: Atypical or secondary parkinsonism Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30 Psychological disorders (illusion, delusion, schizophrenia) Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24 Epilepsy Medial history of brain surgery Medical history of other brain diseases Hemorrhagic tendency Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer Experience of participating in clinical trial within 30 days Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls Pregnant or lactating women Patients who are not considered to be eligible to participate in clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mesencephalic Neuronal Precursor Cells<br> | Drug: Mesencephalic Neuronal Precursor Cells<br>* All the patients are continuously registered for this study. Data monitoring committee inspects the clinical results of first patient and decides whether the treatment for four subjects are appropriate to proceed. 5 subjects of each group are subject to inspection by Data monitoring committee after the end of tracking fifth patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of cancer foramtion and infection | If not included in the following criteria, the cells are are considered to be safe and tolerable. Cells with grade 3 or more in NCI grading system Cells contaminated with infectious materials Cells with risk of cancer formation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS, most commonly used, is designed to assess the severity of parkinson's disease, making the quantitative measurement of the extent. Part III of UPDRS corresponds to motor evaluation and is the most reliable for detecting symptomatic progression. UPDRS improvement ratio(%) = ((the value of UPDRS before surgery - the value of UPDRS after surgery) / (the value of UPDRS before surgery)) X 100 | 5 years | 
| Detection of positron emission in Putamen using Positron emission tomograph(PET) | In pet analysis, putamen activity is investigated via radioactivity before cell transplantation and 12,24,36,48,60 months after the treatment. | 5 years | 
| Dyskinesia scale scores(CAPSIT-PD) | Overall inspection was carried out before transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months after the treatment for determining whether the cells have therapeutic effects. | 5 years | 
| Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test | Comprehensive clinical assessment for examining the improvements in self reporting and timed testing before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment:Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test. | 5 years | 
| Score of activity of daily living (ADL) scale | Comprehensive clinical assessment for examining the improvements in activity of daily living before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years | 
| Score of Korean mini-mental examination (K-MMSE) | Comprehensive clinical assessment for examining the improvements in mental state before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years | 
| Motor fluctuation scale scores | Comprehensive clinical assessment for identifying the presence of motor fluctuation symptoms before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years | 
| Satisfaction score with patient questionnaire | Measure of patient satisfaction before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years | 
| Dopaminergic drug dose | Measure of dopaminergic drug dose before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years | 
| Tremor, postural instability, motor dysfunction, gait disturbance | Using video recording, assessment for symptoms such as tremor, postural instability, motor dysfunction and gait disturbance before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years | 
| Assessing the extent of recovery with patient's diary | Assessing the extent of recovery based on patient's diary before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. | 5 years |