Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial
Dopason is a phase I, open-label, multicenter, single-arm clinical trial designed to evaluate the safety and feasibility of intraputaminal transplantation of human embryonic stem cell-derived dopaminergic progenitor cells (DopaCells) in patients with moderately severe Parkinson's disease.
• Age: 30-70 years
• Diagnosis of PD: MDS clinical Diagnostic Criteria for Parkinson's disease
• The disease duration more than 5 years
• Moderate Parkinson's disease, defined as a Hoehn and Yahr stage of 2 or 3 during the OFF period.
• The patient is receiving oral pharmacological therapy, and in the opinion of the Principal Investigator, the patient's symptoms remain inadequately controlled despite optimal medical management, or the patient is experiencing adverse effects related to their current treatment
• No history or only mild levodopa-induced dyskinesia, defined as a score of 2 or less on the UDysRS scale in any body region during the ON state.
• The patient demonstrates a clinically meaningful response to a therapeutic dose of levodopa, as determined by the Principal Clinical Investigator or a trained specialist under the supervision of the Principal Investigator.
• The performance of different organs based on laboratory evaluations:
‣ Number of neutrophils ≥2000 / microliter
⁃ Platelet count ≥100,000 / microliter
⁃ AST / ALT: less than or equal to three times the maximum normal value at the intervention site
⁃ Total bilirubin less than or equal to 1.5 times the maximum normal amount at the intervention site
⁃ eGFR \* rate: greater than or equal to 60 ml / min / 1.73 m2 \* eGFR (mL / min / 1.73 m2) = 194 X Cr \^ -1.094 X age \^ -0.287 (X 0.739 for females)
• Informed consent