AzTrials
AzTrials

Parkinson's DiseasePhase 1/2NCT05887466

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

A Phase 1/2 study testing Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low Dose and Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High Dose in people with Parkinson's Disease, run by S.Biomedics Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low Dose and Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High Dose
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
9 May 2023to 10 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • ≥ 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722

Other trials in South Korea

About this study

Official 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

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.

Read more

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.
Read the detailed description

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
  2. MDS-UPDRS Total Score, part Ⅲ \& part Ⅳ (defined on/off)
  3. K-MMSE
  4. Seoul Neuropsychological screening battery (SNSB, Screening \& Week 96 (24 months))
  5. Hoehn \& Yahr scale
  6. 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
  7. K-MoCA
  8. Parkinson's Questionnaire (PDQ-39)
  9. Schwab and England ADL scale (SEADL) 4Non-Motor Symptoms Scale for Parkinson's Disease (NMS)
  10. 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.
  11. 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:
  12. Total waking time
  13. Total on-time
  14. Total off-time
  15. Total dyskinesia time

[Other Safety Endpoints]

  1. Vital signs
  2. Laboratory tests
  3. Physical examination
Being tested
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
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low DoseBiological

    Biological/Vaccine: Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC)_Low Dose

    1. IP Name : Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC)
    2. Main ingredients and quantities: A9-DPC -Low Dose : 7.0X10^6 cells (Use 3.15X10^6 cells of this)
    3. Formulation: milky white cell suspension
    4. Storage method: Refrigerated storage (5±3#)
    5. Expiration date: within 36 hours of manufacture
    6. Frequency: single dosing
    7. Method: The subject pierces a burr hole in the skull on the day of surgery. Then the cells are injected at a predetermined stem cell administration point of the putamen in the brain of the subject. One side is administered in three tracks per putamen (6 tracks total brain). Do the same for the other side.

  • Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High DoseBiological

    Biological/Vaccine: Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC)_High Dose

    1. IP Name : Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC)
    2. Main ingredients and quantities: A9-DPC -High Dose : 1.4X10^7 cells (Use 6.30X10^6 cells of this)
    3. Formulation: milky white cell suspension
    4. Storage method: Refrigerated storage (5±3#)
    5. Expiration date: within 36 hours of manufacture
    6. Frequency: single dosing
    7. Method: The subject pierces a burr hole in the skull on the day of surgery. Then the cells are injected at a predetermined stem cell administration point of the putamen in the brain of the subject. One side is administered in three tracks per putamen (6 tracks total brain). Do the same for the other side.
Study groups in NCT05887466
Study groupRoleWhat they receive
Low Dose GroupExperimental1. IP Name : Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) 2. Study group : 6 subjects 3. Dosage: 3.15X10^6 cells/body (6 tracks in total, 52.5X10^4 cells per track)
Receives: Biological: Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low Dose
High Dose GroupExperimental1. IP Name : Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) 2. Study group : 6 subjects 3. Dosage: 6.30X10^6 cells/body (6 tracks in total, 105X10^4 cells per track)
Receives: Biological: Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP

    Present frequency and percentage by each dose group about occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP

    Measured: Up to 96 Weeks (24 months) after IP administration

  2. Failure or rejection of transplantation

    Present frequency and percentage by each dose group about failure or rejection of transplantation at Week 12 (3 months) after administration of the IP

    Measured: Week 12 (3 months)

  3. Failure or rejection of transplantation

    Present frequency and percentage by each dose group about failure or rejection of transplantation at Week 24 (6 months) after administration of the IP

    Measured: Week 24 (6 months)

  4. Failure or rejection of transplantation

    Present frequency and percentage by each dose group about failure or rejection of transplantation at Week 48 (12 months) after administration of the IP

    Measured: Week 48 (12 months)

  5. Failure or rejection of transplantation

    Present frequency and percentage by each dose group about failure or rejection of transplantation at Week 96 (24 months) after administration of the IP

    Measured: Week 96 (24 months)

  6. Occurrence of bleeding

    Present frequency and percentage by each dose group about occurrence of bleeding at Week 12 (3 months) after administration of the IP

    Measured: Week 12 (3 months)

  7. Occurrence of bleeding

    Present frequency and percentage by each dose group about occurrence of bleeding at Week 24 (6 months) after administration of the IP

    Measured: Week 24 (6 months)

  8. Occurrence of bleeding

    Present frequency and percentage by each dose group about occurrence of bleeding at Week 48 (12 months) after administration of the IP

    Measured: Week 48 (12 months)

  9. Occurrence of bleeding

    Present frequency and percentage by each dose group about occurrence of bleeding at Week 96 (24 months) after administration of the IP

    Measured: Week 96 (24 months)

  10. Occurrence of infection

    Present frequency and percentage by each dose group about occurrence of infection at Week 12 (3 months) after administration of the IP

    Measured: Week 12 (3 months)

  11. Occurrence of infection

    Present frequency and percentage by each dose group about occurrence of infection at Week 24 (6 months) after administration of the IP

    Measured: Week 24 (6 months)

  12. Occurrence of infection

    Present frequency and percentage by each dose group about occurrence of infection at Week 48 (12 months) after administration of the IP

    Measured: Week 48 (12 months)

  13. Occurrence of infection

    Present frequency and percentage by each dose group about occurrence of infection at Week 96 (24 months) after administration of the IP

    Measured: Week 96 (24 months)

  14. Occurrence of adverse event of special interest (AESI)* after administration of the IP

    Present frequency and percentage by each dose group about 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.

    Measured: Up to 96 Weeks (24 months) after IP administration

Secondary outcomes (13)

  1. Change in the MDS-UPDRS Total Score, part Ⅲ (defined on/off) & part Ⅳ

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the MDS-UPDRS Total Scores, part Ⅲ (defined on/off) \& part Ⅳ up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 14 to -Day 4).

    • Defined-on condition: condition that the most positive functional effect, as agreed by the subject and the tester, after treatment with drugs for controlling the symptoms of Parkinson's disease
    • Defined-off condition: condition after 12 hours off drugs for controlling the symptoms of Parkinson's disease

    Measured: -Day 14 to -Day 4, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  2. Change in the K-MMSE

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the K-MMSE up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 14 to -Day 4).

    Measured: -Day 14 to -Day 4, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  3. Change in the Seoul Neuropsychological screening battery (SNSB, Screening & Week 96 (24 months))

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the Seoul Neuropsychological Screening battery (SNSB) between baseline (-Day 14 to -Day 4) and 96 Weeks (24 months) after IP administration.

    Measured: -Day 14 to -Day 4, Week 96

  4. Hoehn & Yahr scale

    Change in the Hoehn \& Yahr scale

    Measured: Day 14 to -Day 4, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  5. Change in the K-MoCA

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the K-MoCA up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 2).

    Measured: -Day 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  6. Change in the Parkinson's Questionnaire (PDQ-39)

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the Parkinson's Questionnaire (PDQ-39) up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 2).

    Measured: -Day 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  7. Change in the Schwab and England ADL scale (SEADL)

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the Schwab and England ADL scale (SEADL) up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 2).

    Measured: -Day 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  8. Change in the Non-Motor Symptoms Scale for Parkinson's Disease (NMS)

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about changes in the Non-Motor Symptoms Scale for Parkinson's Disease (NMS) up to 96 Weeks (24 months) after IP administration compared to baseline (-Day 2).

    Measured: -Day 2, Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  9. Change in Graft size through MRI

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about 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 (-Day 2)

    Measured: -Day 2, Week 12, Week 24, Week 48, Week 96

  10. Change in Cerebral FDG uptake and Striatal FDG uptake

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about 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 (-Day 2)

    Measured: -Day 2, Week 48, Week 96

  11. Change in density of dopamine transporters as measured by FP-CIT PET

    Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about 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 (-Day 14 to -Day 4)

    Measured: -Day 14 to -Day 4, Week 48, Week 96

  12. 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)

    Present the frequency and percentage use of concomitant medication related to Parkinson-mobility or Parkinson-Non-mobility during the whole clinical trial period by each dose group.

    Also Present descriptive statistics (number of subjects, average, standard deviation, median, minimum, maximum) by each dose group about 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.

    Measured: Day 0 (Postoperative day #0), Week 4, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96

  13. Parkinson's Disease diary

    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: total waking hours [hours], 2) Total on-time: hours with drug effect [hours], 3)Total off-time: hours without drug effect [hours], 4)Total dyskinesia time: hours with dyskinesia [hours]

    Measured: Day 0 (POD #0), Week 48, Week 72, Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start9 May 2023
  3. Primary completion10 Dec 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
3+3 rule-based method
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887466
Sponsor's protocol ID
SB-PD-001
Status last verified
May 2025
First submitted
9 Apr 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rowland NC, Starr PA, Larson PS, Ostrem JL, Marks WJ Jr, Lim DA. Combining cell transplants or gene therapy with deep brain stimulation for Parkinson's disease. Mov Disord. 2015 Feb;30(2):190-5. doi: 10.1002/mds.26083. Epub 2014 Dec 17.

    PubMed 25521796

  • Schweitzer JS, Song B, Herrington TM, Park TY, Lee N, Ko S, Jeon J, Cha Y, Kim K, Li Q, Henchcliffe C, Kaplitt M, Neff C, Rapalino O, Seo H, Lee IH, Kim J, Kim T, Petsko GA, Ritz J, Cohen BM, Kong SW, Leblanc P, Carter BS, Kim KS. Personalized iPSC-Derived Dopamine Progenitor Cells for Parkinson's Disease. N Engl J Med. 2020 May 14;382(20):1926-1932. doi: 10.1056/NEJMoa1915872.

    PubMed 32402162

  • Barker RA, Drouin-Ouellet J, Parmar M. Cell-based therapies for Parkinson disease-past insights and future potential. Nat Rev Neurol. 2015 Sep;11(9):492-503. doi: 10.1038/nrneurol.2015.123. Epub 2015 Aug 4.

    PubMed 26240036

  • Kikuchi T, Morizane A, Doi D, Magotani H, Onoe H, Hayashi T, Mizuma H, Takara S, Takahashi R, Inoue H, Morita S, Yamamoto M, Okita K, Nakagawa M, Parmar M, Takahashi J. Human iPS cell-derived dopaminergic neurons function in a primate Parkinson's disease model. Nature. 2017 Aug 30;548(7669):592-596. doi: 10.1038/nature23664.

    PubMed 28858313

  • Mendez I, Sanchez-Pernaute R, Cooper O, Vinuela A, Ferrari D, Bjorklund L, Dagher A, Isacson O. Cell type analysis of functional fetal dopamine cell suspension transplants in the striatum and substantia nigra of patients with Parkinson's disease. Brain. 2005 Jul;128(Pt 7):1498-510. doi: 10.1093/brain/awh510. Epub 2005 May 4.

    PubMed 15872020

  • Parmar M, Grealish S, Henchcliffe C. The future of stem cell therapies for Parkinson disease. Nat Rev Neurosci. 2020 Feb;21(2):103-115. doi: 10.1038/s41583-019-0257-7. Epub 2020 Jan 6.

    PubMed 31907406

  • Barker RA; TRANSEURO consortium. Designing stem-cell-based dopamine cell replacement trials for Parkinson's disease. Nat Med. 2019 Jul;25(7):1045-1053. doi: 10.1038/s41591-019-0507-2. Epub 2019 Jul 1.

    PubMed 31263283

  • Dubois B, Burn D, Goetz C, Aarsland D, Brown RG, Broe GA, Dickson D, Duyckaerts C, Cummings J, Gauthier S, Korczyn A, Lees A, Levy R, Litvan I, Mizuno Y, McKeith IG, Olanow CW, Poewe W, Sampaio C, Tolosa E, Emre M. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007 Dec;22(16):2314-24. doi: 10.1002/mds.21844.

    PubMed 18098298

  • Baek MJ, Kim K, Park YH, Kim S. The Validity and Reliability of the Mini-Mental State Examination-2 for Detecting Mild Cognitive Impairment and Alzheimer's Disease in a Korean Population. PLoS One. 2016 Sep 26;11(9):e0163792. doi: 10.1371/journal.pone.0163792. eCollection 2016.

    PubMed 27668883

  • Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8. doi: 10.1002/mds.20213.

    PubMed 15372591

  • Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.

    PubMed 11775596

  • Koh SB, Kim JW, Ma HI, Ahn TB, Cho JW, Lee PH, Chung SJ, Kim JS, Kwon DY, Baik JS. Validation of the korean-version of the nonmotor symptoms scale for Parkinson's disease. J Clin Neurol. 2012 Dec;8(4):276-83. doi: 10.3988/jcn.2012.8.4.276. Epub 2012 Dec 21.

    PubMed 23323136

  • Shulman LM, Armstrong M, Ellis T, Gruber-Baldini A, Horak F, Nieuwboer A, Parashos S, Post B, Rogers M, Siderowf A, Goetz CG, Schrag A, Stebbins GT, Martinez-Martin P. Disability Rating Scales in Parkinson's Disease: Critique and Recommendations. Mov Disord. 2016 Oct;31(10):1455-1465. doi: 10.1002/mds.26649.

    PubMed 27193358

  • Park HJ, Sohng KY, Kim S. Validation of the Korean version of the 39-Item Parkinson's Disease Questionnaire (PDQ-39). Asian Nurs Res (Korean Soc Nurs Sci). 2014 Mar;8(1):67-74. doi: 10.1016/j.anr.2014.02.004. Epub 2014 Mar 6.

    PubMed 25030495

  • Kefalopoulou Z, Politis M, Piccini P, Mencacci N, Bhatia K, Jahanshahi M, Widner H, Rehncrona S, Brundin P, Bjorklund A, Lindvall O, Limousin P, Quinn N, Foltynie T. Long-term clinical outcome of fetal cell transplantation for Parkinson disease: two case reports. JAMA Neurol. 2014 Jan;71(1):83-7. doi: 10.1001/jamaneurol.2013.4749.

    PubMed 24217017

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) Low Dose and Allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) High Dose in people with Parkinson's Disease, run by S.Biomedics Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP (time frame: Up to 96 Weeks (24 months) after IP administration). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05887466, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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