Parkinson's breakthrough? stem cells show promise in early trial
NCT ID NCT05887466
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new stem cell treatment for Parkinson's disease in 12 people who had been diagnosed at least 5 years earlier. The treatment uses dopamine-producing cells made from embryonic stem cells, injected into the brain. The main goal was to check safety, but researchers also looked for signs that it might slow or reverse the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- embryonic stem cell-derived dopamine progenitor cells
- What this could lead to
- If this works, it could point toward a treatment that slows or stops Parkinson's progression, or even helps repair damaged brain areas.
- What could go wrong
- This is a very early, small trial (12 people) focused mainly on safety. The treatment may not work, and there are risks like tumors or immune reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
12 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yonsei University Health System, Severance Hospital
Seoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Colon tissue may hold clues to telling Parkinson's apart from Look-Alike diseases
- A genetic roadmap for Parkinson's: testing thousands to unlock clues
- Can gentle touch therapy calm Parkinson's tremors?
- Stem cell infusions aim to slow Parkinson's progression
- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.