Status:
UNKNOWN
Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
Lead Sponsor:
Bundang CHA Hospital
Conditions:
Idiopathic Parkinson Disease
Primary Parkinsonism
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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
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 evaluate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01860794
Start Date
May 1 2013
End Date
April 1 2022
Last Update
July 10 2020
Active Locations (1)
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1
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea, 463-712