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Brain stem cell injection aims to restore movement in Parkinson's

NCT ID NCT07212088

Disease control Sponsor: iCamuno Biotherapeutics Ltd. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tests a single injection of lab-grown dopamine-producing cells into the brains of 12 people with advanced Parkinson's disease. The goal is to see if the procedure is safe and if it can improve motor function and quality of life. Participants must be between 55 and 75 years old, have had Parkinson's for over 5 years, and experience daily 'off' periods despite medication.

What this could mean

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

Active substance
ALC01 therapy (iPSC-derived dopamine progenitor cells)
What this could lead to
If successful, this could point toward a cell-based treatment that restores dopamine function and improves motor symptoms in Parkinson's disease.
What could go wrong
This is a very early Phase 1 trial with only 12 participants, so safety and feasibility are the main focus. The procedure involves brain surgery, which carries risks like bleeding or infection, and the cells may not survive or work as hoped.

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.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

55 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: * Able to sign informed consent and comply with the study protocol * 55-75 years of age, at the time of signing informed consent * Diagnosed to be Parkinson's disease patients over 5 years * Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia * At least 3 hours accumulative "off" time per day * Hoehn and Yahr Stage 3 - 4 in the off state at screening * Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale Exclusion Criteria: * Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack * Patient with unstable vital sign at screening and/or prior to the surgery * Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2 * Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN. * Hematologic abnormality: hemoglobin \<10 mg/dL or platelet count \< 100,000/mL * International normalized ratio (INR) ≥ 1.3 not due to a reversible cause * Patients with autoimmune disorders * Patients with HIV and/or active HBV or HCV * Patients who are unable to undergo MRI and PET/CT * Patients with an expected life expectancy of \<1 year * Patients who have had active malignancies * Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment * Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery * Received cell or gene therapy (autologous or allogeneic) within the previous 12 months * Participation in an investigational therapeutic or device trial within 30 days of consent * Women who are pregnant or breast-feeding * Other conditions that researchers consider not suitable to participate in this study

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

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

  • Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

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