Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients

Korábbi kezelés

• Drug-induced parkinsonism
• History of uncontrolled seizure disorders within 24 weeks before screening
• Participation in another clinical trial within 4 weeks before screening
• History of treatment with cell therapy, except for blood transfusion, before study participation
• Positive pregnancy test at the time of screening; or woman of childbearing potential and man who plan a pregnancy during the study or who do not agree to use clinically appropriate methods of contraception* described below Hormone contraceptives (subdermal contraceptive implants, injections, oral contraceptives, etc.), intrauterine device (IUD) (or intra uterine system [IUS]), subject's or partner's surgical sterilization (vasectomy, tubal ligation, etc.), double barrier method (combined use of barrier methods such as cervical cap or diaphragm in combination with male condom)

Más betegség

• Parkinson's disease dementia based on the Movement Disorders Society Task Force criteria
• Parkinsonism plus syndrome confirmed by PET and MRI images at the screening visit
• Patient that does not meet the criteria for Parkinson's disease dementia but has major visual hallucination
• Past or current coagulation factor related diseases at the time of the screening visit
• Ongoing malignancies at the time of the screening visit or diagnosis of malignancies within the past 5 years
• Patient diagnosed with diabetes mellitus
• History of brain surgery

Laborértékek

• Active tuberculosis, autoimmune disease, or decreased immunity at the time of the screening visit (treatment with chemotherapy within the past 3 years or white blood cell [WBC] <3X10\^3 cells/µL)
• Past or current clinically significant diseases in the liver (including liver transplant), kidney, respiratory system, cardiovascular system, etc. or clinically significant laboratory test results at the time of the screening visit
  • Platelet count < 5.0X10\^4/microL
  • Serum creatinine > 1.5 mg/dL
  • eGFR < 60 mL/min/1.73 m\^2
  • AST or ALT ≥ 3 x ULN (Upper Limit of Normal)
  • Total bilirubin ≥ 1.5 x ULN (Upper Limit of Normal)
  • Hepatitis B or C
  • Human immunodeficiency virus (HIV) positive

Egyéb

• Freezing of gait with no or ambiguous response to L-dopa
• Congenital developmental delay
• Side effects to anesthetics, contrast agents, etc.
• Pregnant and lactating woman
• Ineligible for other reasons based on the judgment of the investigator

• Patient with Parkinson's disease based on UK PD Society Brain Bank criteria at the time of the screening visit
• Patient with Parkinson's disease at the age of 50 to 75 years old at the time of the screening visit
• Patient who was diagnosed with Parkinson' disease ≥ 5 years ago at the time of the screening visit
• Patient on a stable dose of medicine such as levodopa for ≥ 3 months before screening who has wearing off for ≥ 2 hours a day or freezing of gait responding to dopamine supplement or motor complications such as dyskinesia
• At least moderate impairment in activity of daily living (MDS-UPDRS part II ≥13)
• Patient on a stabile dose of standard treatment for Parkinson's disease (e.g., levodopa, dopamine agonists, MAO-B inhibitors, amantadine, anticholinergics, etc.) for ≥ 3 months before screening
• ≥ 40% in L-dopa responsiveness at the time of the screening visit
• Hoehn \& Yahr stage ≥ 3 during the off state and stage ≤ 3 during the on state at the time of the screening visit
• Decreased dopamine transporters as measured by FP-CIT PET at the time of the screening visit
• Able to undergo MRI
• Signed consent after being sufficiently informed of the study