Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
- Conditions
- Idiopathic Parkinson DiseasePrimary Parkinsonism
- Interventions
- Drug: Mesencephalic Neuronal Precursor Cells
- Registration Number
- NCT01860794
- Lead Sponsor
- Bundang CHA Hospital
- 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 evaluated by Data monitoring committee before the enrolment of next human subject.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mesencephalic Neuronal Precursor Cells Mesencephalic Neuronal Precursor Cells -
- Primary Outcome Measures
Name Time Method Presence or absence of cancer foramtion and infection 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
- Secondary Outcome Measures
Name Time Method Score of Unified Parkinson's Disease Rating Scale (UPDRS) 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 100Detection of positron emission in Putamen using Positron emission tomograph(PET) 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) 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 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 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) 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 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 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 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 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 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.
Trial Locations
- Locations (1)
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of