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Stem cell injection aims to replace lost brain cells in Parkinson's

NCT ID NCT07166757

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a single injection of lab-grown nerve cells made from stem cells to treat early-onset Parkinson's disease. The cells are designed to replace the dopamine-producing neurons that are lost in Parkinson's. The trial has two phases: first, a small safety test in 6-12 people, then a larger blinded study in 81 people comparing the cell injection to a sham procedure. All participants will also take immunosuppressant drugs to prevent rejection.

What this could mean

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

Active substance
human allogeneic induced pluripotent stem cell-derived dopaminergic neural progenitor cells
What this could lead to
If successful, this could point toward a cell-replacement therapy that restores dopamine-producing neurons and slows Parkinson's progression.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants, so safety and effectiveness are not yet proven. Participants also need to take immunosuppressants, which carry their own risks.

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

About 90 people

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

Started

Sep 2025

Expected to finish

Mar 2029

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

18 to 70 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: * 18 years old ≤ age of onset ≤ 50 years old, diagnosed with EOPD (meeting the MDS 2015 clinical diagnostic criteria for Parkinson's disease ); * 18 years old ≤ age at enrollment ≤ 70 years old , male/female; * Disease duration ≥ 5 years; * Phase I: the modified Hoehn-Yahr grade in the off-phase is 3-4 (including the critical value) , and the modified Hoehn-Yahr grade in the on-phase is ≤3 ; Phase II: the modified Hoehn-Yahr grade in the off-phase is 2-4 (including the critical value) , and the modified Hoehn-Yahr grade in the on-phase is ≤3; * Off-period MDS -UPDRS-III score \>30; * Positive L-dopa stress test; * The patient is unable to adequately control motor fluctuations even with a stable dose of medication recommended in the "Guidelines for the Treatment of Parkinson's Disease in China (Fourth Edition)" ; * Patients received stable doses of anti-PD drugs for at least 4 weeks before administration; * Able to accept surgical anesthesia, suitable for neurosurgery under anesthesia, and able to undergo brain CT /MRI examination; * Participants agree to postpone any other elective neurosurgery until the completion of the 24-month follow-up study; * Participants agreed not to participate in any other clinical studies within 24 months after dosing; * Participants or their legal representatives understand and comply with the research procedures, voluntarily participate and sign the ICF Exclusion Criteria: * Non-primary PD or Parkinson's superimposed syndromes ; * Patients are in the late stages of PD and are experiencing severe, disabling peak-dose dyskinesia or biphasic dyskinesia and/or unpredictable or widely fluctuating symptoms; * Have previously undergone neuronucleotomy, deep brain stimulation (DBS), striatal surgery, extrapyramidal surgery, stereotactic brain surgery, or other brain surgery; or who have undergone other surgical procedures that the investigator determined would affect participation in this study; or who have surgical contraindications * Patients currently receiving L-dopa intestinal instillation, apomorphine injection, or continuous daily infusion of anti-PD drugs; * Patients who had used botulinum toxin, phenol, subarachnoid injection of baclofen, or received interventional treatment for dystonia or spasticity within 6 months before medication; * Have used glucocorticoids or immunosuppressive drugs for a long time within 3 months before the screening visit; * Those who have received cell therapy before; * Patients who received electroconvulsive therapy within 30 days before administration; * Those who have received or plan to receive vaccines during the trial within 3 months before screening, such as vaccines for novel coronavirus pneumonia (COVID-19), influenza, herpes zoster, and pneumococcal vaccine; * Those with a history of mental illness who are judged by the researchers to be unsuitable for study participation; or those with severe suicidal ideation currently or within the year before screening or any history of suicide attempts within the past 2 years; * Those with active epilepsy or currently taking anti-epileptic drugs; * Those with a history of dementia or severe cognitive impairment; or those with obvious dementia or cognitive impairment at screening; dementia may affect participants' poor compliance, inability to accurately record diaries, and / or inability to sign the ICF; * Severe anxiety at screening; * Patients whose previous head CT/MRI examinations showed brain injuries such as brain trauma, cerebral vascular malformation, hydrocephalus, brain tumors, or abnormal brain imaging of the striatum and other brain regions, which significantly increased the surgical risk; * Those with uncontrolled autoimmune diseases; * Patients with a history of severe cardiovascular and cerebrovascular diseases; * Patients with other serious systemic diseases; * During the screening period, patients have severe arthritis, limp, severe sequelae of stroke, severe osteoporosis, or a history of severe trauma within 1 month (such as hip or lower limb fractures), which may affect the study evaluation as assessed by the researchers; * Patients with malignant tumors or a history of malignant tumors; * Patients with active disseminated intravascular coagulation and obvious bleeding tendency within 3 months before signing the ICF, or patients who cannot stop taking antiplatelet drugs or other anticoagulants for at least 10 days before surgery; * Previous history of abnormal coagulation function; * Patients with lab result abnormalities during screening include; * Allergic to the drugs used in the study; * Are pregnant or breastfeeding, or plan to become pregnant during the study; * Female participants of fertile potential must have a positive pregnancy test result before dosing; female participants of fertile potential, or male participants who are not sterilized and whose partners are fertile, must not take effective contraceptive measures from the time they sign the ICF until at least 24 months after dosing; female participants must not agree to not donate eggs from the time they sign the ICF until at least 24 months after dosing, and male participants must not agree to not donate sperm from the time they sign the ICF until at least 24 months after dosing; * Participants who are currently participating in other clinical trials, or have participated in other clinical studies and received intervention treatment within 1 month before administration; * Those who are considered by the researchers to have poor compliance; * Any other situation that the researcher deems to jeopardize the safety of the participants or affect the study evaluation.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

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