Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0009343
- Lead Sponsor
- S.Biomedics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 12
1) Patient with Parkinson's disease based on UK PD Society Brain Bank criteria at the time of the screening visit
2) Patient with Parkinson's disease at the age of 50 to 75 years old at the time of the screening visit
3) Patient who was diagnosed with Parkinson' disease = 5 years ago at the time of the screening visit
4) 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
5) At least moderate impairment in activity of daily living (MDS-UPDRS part II =13)
6) 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
7) = 40% in L-dopa responsiveness at the time of the screening visit
8) Hoehn & Yahr stage = 3 during the off state and stage = 3 during the on state at the time of the screening visit
9) Decreased dopamine transporters as measured by FP-CIT PET at the time of the screening visit
10) Able to undergo MRI
11) Signed consent after being sufficiently informed of the study
1) Parkinson's disease dementia based on the Movement Disorders Society Task Force criteria
2) Parkinsonism plus syndrome confirmed by PET and MRI images at the screening visit
3) Patient that does not meet the criteria for Parkinson's disease dementia but has major visual hallucination
4) Freezing of gait with no or ambiguous response to L-dopa
5) Drug-induced parkinsonism
6) History of uncontrolled seizure disorders within 24 weeks before screening
7) Congenital developmental delay
8) Past or current coagulation factor related diseases at the time of the screening visit
9) Ongoing malignancies at the time of the screening visit or diagnosis of malignancies within the past 5 years
10) 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)
11) Patient diagnosed with diabetes mellitus
12) Participation in another clinical trial within 4 weeks before screening
13) History of treatment with cell therapy, except for blood transfusion, before study participation
14) Side effects to anesthetics, contrast agents, etc.
15) 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
16) History of brain surgery
17) Pregnant and lactating woman
18) 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)
19) Ineligible for other reasons based on the judgment of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP;Failure or rejection of transplantation and occurrence of bleeding and infection at Week 12 (3 months), Week 24 (6 months), Week 48 (12 months) and Week 96 (24 months) after administration of the IP;Occurrence of adverse event of special interest (AESI)* after administration of the IP (*AESI: a) death, b) generation of a neoplasm or malignant tumor in tissues or organs, c) onset of an immune reaction including worsening of a previous autoimmune disease or new occurrence, and d) other delayed adverse events related to this embryonic stem cell treatment.)
- Secondary Outcome Measures
Name Time Method