Own cells implanted in brain to fight Parkinson's
NCT ID NCT06778265
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 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: 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
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Other studies related to the condition(s) this trial covers.
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