The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients.
Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Bilateral implantation
Incidence and severity of adverse events.
Safety and tolerability
Time frame: Within 24 months post-transplantation
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
Time frame: Within 24 months post-transplantation
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.
Higher scores mean a worse outcome.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Time frame: Within 24 months post-transplantation
Assessment of changes in Mini-mental State Examination (MMSE), Hamilton Depression Scale (HAMD)-17 and Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Time frame: Within 24 months post-transplantation
Assessment of changes in Activity of Daily Living Scale (ADL) in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in activity of daily living.
Time frame: Within 24 months post-transplantation
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Brain network connectivity patterns as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
Evidence of cell survival
Time frame: Within 24 months post-transplantation
Brain DAT intake index as demonstrated on PET dopamine transporter(DAT) compared with baseline in the 'off' state.
Evidence of cell survival
Time frame: Within 24 months post-transplantation
Patient L-dopa equivalent dose compared with baseline.
Measure of dopaminergic drug dose.
Time frame: Within 24 months post-transplantation