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Parkinson's breakthrough? stem cells show promise in early trial

NCT ID NCT05887466

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • 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.