Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
NCT ID: NCT01860794
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2013-05-31
2022-04-30
Brief Summary
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Detailed Description
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The progress of the clinical trails is reported to and evaluated by Data monitoring committee before the enrolment of next human subject.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mesencephalic Neuronal Precursor Cells
Mesencephalic Neuronal Precursor Cells
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.
Interventions
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Mesencephalic Neuronal Precursor Cells
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
FEMALE
Yes
Sponsors
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Bundang CHA Hospital
OTHER
Responsible Party
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Sang Sup Chung
Professor
Principal Investigators
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Sang Sup Chung, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CHA University
Locations
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CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PBC09-074
Identifier Type: -
Identifier Source: org_study_id
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