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Own cells implanted in brain to fight Parkinson's

NCT ID NCT06778265

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new treatment called UX-DA001 for people with Parkinson's disease. The treatment uses the patient's own cells, which are turned into dopamine-producing cells and implanted into the brain during surgery. The main goal is to check safety, but researchers will also look for signs that motor function improves. Only 12 people aged 50-75 with advanced Parkinson's will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UX-DA001 (human midbrain dopaminergic progenitor cells made from the patient's own cells)
What this could lead to
If it works, this could point toward a treatment that replaces lost dopamine cells and improves motor function in Parkinson's disease.
What could go wrong
This is a very early Phase 1 trial with only 12 people, focused on safety. It may not improve symptoms, and surgery carries risks like bleeding or infection.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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: 1. The subjects or their legally acceptable representative understand and comply with the study procedures, agree to participate in the clinical trial, and sign the ICF; 2. Aged between 50-75 years old, male or female; 3. Subjects diagnosed with idiopathic PD, with a medical history of 5-20 years; 4. Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined; 5. Good response to levodopa medications; the LCT shows that the maximum improvement rate of the UPDRS part III score exceeds 30%; 6. The modified H\&Y scale of clinical "OFF" period is ≥ Stage 3 and ≤ Stage 4; 7. Taking a stable dosage of anti-PD medications for at least 4 weeks; 8. Good physical condition or stable concomitant diseases; 9. With reliable caregivers who can cooperate to complete the assessment items; 10. Subjects with good compliance. Exclusion Criteria: 1. PD Subjects in whom previous genetic testing has found a GBA gene mutation or PD Subjects whom the investigator considers unsuitable for participation in this clinical study due to other gene mutations; 2. Subjects with the atypical Parkinson's syndrome or secondary Parkinson's syndrome; 3. Subjects with HIV, HBV, HCV, treponema pallidum (TP) infection, or other active infections; 4. Subjects infected with HTLV, EBV or CMV whose infection renders their blood cells unsuitable for cell product preparation; 5. Subjects with a known hereditary disorder; 6. Subjects with any history of malignancy; 7. Subjects with other serious systemic diseases or functional disorders; 8. Accompanied by other serious central nervous system diseases or serious cognitive and mental disorders; 9. Subjects who are currently receiving or have previously received cell therapy or other medicine effecting safety and efficacy assessement; 10. Subjects whose prior head CT/MRI examinations indicate brain injury, or Subjects with imaging abnormalities in the striatum and other brain regions leading to a significant increase in surgical risk, or Subjects who have previously undergone brain surgery; 11. Subjects with clinically significant abnormal results in coagulation function, or Subjects who have been using anticoagulants for a long time and cannot discontinue use; 12. Subjects with a history of severe allergy or hypersensitivity reactions, or a known history of hypersensitivity, or a history of intolerance to the investigational cellular drug or its excipients; 13. Subjects who have undergone other surgeries within the past six months that the investigator deems may affect this trial, or Subjects who cannot tolerate general anesthesia or stereotactic surgery; 14. Subjects with contraindications to MRI and PET scans; 15. Subjects with a history of alcoholism or drug abuse; 16. Women during pregnancy or lactation; 17. Subjects who have participated in other interventional clinical trials or similar clinical trials within the past 3 months; 18. Subjects with other conditions that are not suitable for participation in the clinical study as judged by 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

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.