Completed · registry statusStudy to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients
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Testing a treatment or activity · Study reference: NCT05887466
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Completed; watching for results
- Start (reported actual date)
- 2023-05-09
- Main measurements finished (reported actual date)
- 2025-12-10
- Study finished (reported actual date)
- 2025-12-10
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Participation rules recorded for this study
Ages 50 years to 75 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Freezing of gait with no or ambiguous response to L-dopa
* Drug-induced parkinsonism
* History of uncontrolled seizure disorders within 24 weeks before screening
* Congenital developmental delay
* 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
* 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)
* Patient diagnosed with diabetes mellitus
* Participation in another clinical trial within 4 weeks before screening
* History of treatment with cell therapy, except for blood transfusion, before study participation
* Side effects to anesthetics, contrast agents, etc.
* 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
1. Platelet count \< 5.0X10\^4/microL
2. Serum creatinine \> 1.5 mg/dL
3. eGFR \< 60 mL/min/1.73 m\^2
4. AST or ALT ≥ 3 x ULN (Upper Limit of Normal)
5. Total bilirubin ≥ 1.5 x ULN (Upper Limit of Normal)
6. Hepatitis B or C
7. Human immunodeficiency virus (HIV) positive
* History of brain surgery
* Pregnant and lactating woman
* 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)
* Ineligible for other reasons based on the judgment of the investigator
Full study name & original research details
Official study title
A Single Center, Open, Single Dosing, Dose-escalation, Phase 1/2a Study to Evaluate the Safety and Exploratory Efficacy of Embryonic Stem Cell-derived A9 Dopamine Progenitor Cell (A9-DPC) Therapy in Patients With Parkinson's Disease
Short title used by the registry
Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD Patients
Original description
Indication: Patients who were diagnosed with Parkinson's disease ≥ 5 years ago.
Purpose: To find the maximum tolerable dose and evaluate the safety and exploratory efficacy of allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) therapy in patients who were diagnosed with Parkinson's disease ≥ 5 years ago, as a treatment for delaying or stopping the progression of Parkinson's disease or inducing recovery of damaged brain.
Number of Subjects: Up to 12 subjects. \[Low dose\] 3.15X10\^6 cells/body: 6 subjects. \[High dose\] 6.30X10\^6 cells/body: 6 subjects.
Study Design: Single center, open, single dosing, dose-escalation, phase 1/2a study
Endpoints:
\[Primary Safety Endpoints\]
1. Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP
2. Failure or rejection of transplantation and occurrence of bleeding and infection at Week 12 (3months), Week 24 (6months), Week 48 (12months) and Week 96 (24months) after administration of the IP
3. 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.
Further description from the registry
Study Period: Approximately 35 months from the date of approval by the Institutional Review Board (IRB) (However, it can be extended depending on the subject enrollment period or the time to study closure)
Indication: Patients who were diagnosed with Parkinson's disease ≥ 5 years ago
Purpose: To find the maximum tolerable dose and evaluate the safety and exploratory efficacy of allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) therapy in patients who were diagnosed with Parkinson's disease ≥ 5 years ago, as a treatment for delaying or stopping the progression of Parkinson's disease or inducing recovery of damaged brain.
Number of Subjects: Up to 12 subjects \[Low dose\] Dose: 3.15X10\^6 cells/body Study group(A9-DPC): 6 subjects \[High dose\] Dose: 6.30X10\^6 cells/body Study group(A9-DPC): 6 subjects
Study Design: Single center, open, single dosing, dose-escalation, phase 1/2a study
Endpoints:
\[Primary Safety Endpoints\]
1. Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP
2. 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
3. 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.
\[Exploratory Efficacy Endpoints\]
1\. Change in the following clinical endpoints at Week 4 (1 month), Week 12 (3 months), Week 24 (6 months), Week 36 (9 months), Week 48 (12 months), Week 72 (18 months) and Week 96 (24 months) after administration of the IP compared to screening
1. MDS-UPDRS Total Score, part Ⅲ \& part Ⅳ (defined on/off)
2. K-MMSE
3. Seoul Neuropsychological screening battery (SNSB, Screening \& Week 96 (24 months))
4. Hoehn \& Yahr scale
2\. Change in the following clinical endpoints at Week 4 (1 month), Week 12 (3 months), Week 24 (6 months), Week 36 (9 months), Week 48 (12 months), Week 72 (18 months) and Week 96 (24 months) after administration of the IP compared to baseline
1. K-MoCA
2. Parkinson's Questionnaire (PDQ-39)
3. Schwab and England ADL scale (SEADL) 4Non-Motor Symptoms Scale for Parkinson's Disease (NMS)
3\. Change in Graft size through MRI at Week 12 (3 months), Week 24 (6 months), Week 48 (12 months) and Week 96 (24 months) after administration of the IP compared to baseline 4. Change in Cerebral FDG uptake and Striatal FDG uptake at Week 48 (12 months) and Week 96 (24 months) after administration of the IP compared to baseline 5. Change in density of dopamine transporters as measured by FP-CIT PET at Week 48 (12 months) and Week 96 (24 months) after administration of the IP compared to screening 6. Percentage of subjects who used concomitant medication related to Parkinson-mobility or Parkinson-Non-mobility during the whole clinical trial period and change in dose of each concomitant medication (per component) at 12 week intervals compared to the dose of each concomitant medication (per component) from the date of administration of IP to Week 12.
7\. Changes in the following clinical evaluation variables confirmed through the Parkinson's Disease diary at 48 weeks (12 months), 72 weeks (18 months), and 96 weeks (24 months) after administration of the investigational drug compared to baseline:
1. Total waking time
2. Total on-time
3. Total off-time
4. Total dyskinesia time
\[Other Safety Endpoints\]
1. Vital signs
2. Laboratory tests
3. Physical examination
Conditions reported: Parkinson's Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low Dose; Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High Dose
- Phases
- PHASE1; PHASE2
- Sponsor
- S.Biomedics Co., Ltd.
- Start date reported by registry
- 2023-05-09 (actual)
Registry updated: 2026-04-13 · Status last verified by the registry submitter: 2025-05
Registry records retrieved 2026-10-12 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
No central contact is listed. Check the location contacts or the official registry record.
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.