Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD)
Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation
Provision of signed and dated informed consent form
Aged 45 to 70 years old (inclusive) at Screening
Idiopathic Parkinson's disease patients who meet the diagnostic criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"
With at least 5 years since the diagnosis of Parkinson's disease
Atypical or secondary Parkinsonism
With neurodegenerative disorders other than PD
Unable to receive MRI or PET scanning
With any concomitant disorder that would contraindicate coagulation, general anesthesia, or stereotactic neurosurgery
Sequential
Aadipose-Derived Mesenchymal Stem Cells
Biological/VaccineStereotactic intrastriatal implantation of 3×10\^7 per hemisphere (total 6×10\^7 cells) or 1×10\^8 per hemisphere (total 2×10\^8 cells) autologous TM01-treated adipose-derived mesenchymal stem cells (MitoCell).
Grading of Adverse Events
Grading will be assessed using NCI CTCAE, version 5.0.
Routine physical examinations
Safety of Mitocell will be assessed by routine physical examinations. Physical examination conducted in this study will include general appearance, skin, eyes, ears, nose,throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal,neurological, etc.
Changes in physical examinations: clinical standard neurological examination [Safety of Mitocell]
Clinical standard neurological examination by study investigator. Changes in motor function, sensory function, cranial nerve function (visual fields), cortical functions and reflexes are followed in the examination, scored as normal - abnormal without clinical relevance - abnormal with clinical relevance
Changes in vital signs: blood pressure [Safety of Mitocell]
Changes in blood pressure during the study , measured as systolic and diastolic blood pressure (in mmHg)
MDS-UPDRS (Movement Disorder Society unified Parkinson's disease rating scale)
Change in MDS-UPDRS motor (Part III) "OFF" score compared to the baseline. All items have 5 response options with uniform anchors of: 0 = normal, 1 = slight (symptoms/signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/signs that prevent function).
Modified Hoehn & Yahr staging
Change in Modified Hoehn \& Yahr staging compared to the baseline.
18F-DOPA PET
Degree of radiotracer uptake increment/decrement shown on striatum of 18F-DOPA PET compared to the baseline.
levodopa equivalent daily dose (LEDD)
Reduction of Parkinson's medications consumption by calculating levodopa equivalent daily dose (LEDD) compared to the baseline.
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