Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT01860794 |
Recruitment Status :
Recruiting
First Posted : May 23, 2013
Last Update Posted : July 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Parkinson Disease Primary Parkinsonism | Drug: Mesencephalic Neuronal Precursor Cells | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease |
Study Start Date : | May 2013 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Mesencephalic Neuronal Precursor Cells |
Drug: 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. |
- Presence or absence of cancer foramtion and infection [ Time Frame: 5 years ]
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
- Score of Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 5 years ]
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
- Detection of positron emission in Putamen using Positron emission tomograph(PET) [ Time Frame: 5 years ]In pet analysis, putamen activity is investigated via radioactivity before cell transplantation and 12,24,36,48,60 months after the treatment.
- Dyskinesia scale scores(CAPSIT-PD) [ Time Frame: 5 years ]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.
- Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test [ Time Frame: 5 years ]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.
- Score of activity of daily living (ADL) scale [ Time Frame: 5 years ]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.
- Score of Korean mini-mental examination (K-MMSE) [ Time Frame: 5 years ]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.
- Motor fluctuation scale scores [ Time Frame: 5 years ]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.
- Satisfaction score with patient questionnaire [ Time Frame: 5 years ]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.
- Dopaminergic drug dose [ Time Frame: 5 years ]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.
- Tremor, postural instability, motor dysfunction, gait disturbance [ Time Frame: 5 years ]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.
- Assessing the extent of recovery with patient's diary [ Time Frame: 5 years ]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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860794
Contact: Sang Sup Chung, M.D., Ph.D. | 82-31-780-5261 | jmoon@cha.ac.kr | |
Contact: Joo pyung Kim, M.D., Ph.D. | 82-31-780-5000 | jpkim@cha.ac.kr |
Korea, Republic of | |
CHA Bundang Medical Center, CHA University | Recruiting |
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712 | |
Contact: Sang Sup Chung, M.D., Ph.D. 82-31-780-5261 sschung@cha.ac.kr | |
Contact: In Bo Han, M.D., Ph.D. 82-31-780-5688 hanib@cha.ac.kr | |
Principal Investigator: Sang Sup Chung, M.D., Ph.D. | |
Sub-Investigator: In Bo Han, M.D., Ph.D. | |
Sub-Investigator: Joo Pyung Kim, M.D., Ph.D. | |
Sub-Investigator: Yong Soo Choi, Ph.D. | |
Sub-Investigator: Hyun Sook Kim, M.D., Ph.D. | |
Sub-Investigator: Won Chan Kim, M.D., Ph.D. | |
Sub-Investigator: Sang Heum Kim, M.D., Ph.D. | |
Sub-Investigator: Eun Hye Yoo, M.D., Ph.D. | |
Sub-Investigator: Su Jin Jang, M.D., Ph.D. | |
Sub-Investigator: Jisook Moon, Ph.D. |
Principal Investigator: | Sang Sup Chung, M.D., Ph.D. | CHA University |
Responsible Party: | Sang Sup Chung, Professor, Bundang CHA Hospital |
ClinicalTrials.gov Identifier: | NCT01860794 |
Other Study ID Numbers: |
PBC09-074 |
First Posted: | May 23, 2013 Key Record Dates |
Last Update Posted: | July 10, 2020 |
Last Verified: | July 2020 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |