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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGPresence 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
Time frame: 5 years
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years