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Stem cells injected into brain to fight Parkinson's: first human test

NCT ID NCT07572071

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests whether transplanting 10 million special nerve cells made from stem cells into the brain is safe for people with moderate Parkinson's disease. Ten participants will receive the cells in a single surgery. The main goal is to check for side effects and see if the procedure is feasible, not yet to prove it works.

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 6 people

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

Started

Aug 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 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: * Age: 30-70 years * Diagnosis of PD: MDS clinical Diagnostic Criteria for Parkinson's disease * The disease duration more than 5 years * Moderate Parkinson's disease, defined as a Hoehn and Yahr stage of 2 or 3 during the OFF period. * The patient is receiving oral pharmacological therapy, and in the opinion of the Principal Investigator, the patient's symptoms remain inadequately controlled despite optimal medical management, or the patient is experiencing adverse effects related to their current treatment * No history or only mild levodopa-induced dyskinesia, defined as a score of 2 or less on the UDysRS scale in any body region during the ON state. * The patient demonstrates a clinically meaningful response to a therapeutic dose of levodopa, as determined by the Principal Clinical Investigator or a trained specialist under the supervision of the Principal Investigator. * The performance of different organs based on laboratory evaluations: * Number of neutrophils ≥2000 / microliter * Platelet count ≥100,000 / microliter * AST / ALT: less than or equal to three times the maximum normal value at the intervention site * Total bilirubin less than or equal to 1.5 times the maximum normal amount at the intervention site * eGFR \* rate: greater than or equal to 60 ml / min / 1.73 m2 \* eGFR (mL / min / 1.73 m2) = 194 X Cr \^ -1.094 X age \^ -0.287 (X 0.739 for females) * Informed consent Exclusion Criteria: * The abnormal function of immune system * The symptomatic brain injuries (brain atrophy, cerebral Infarct, trauma, vascular malformation) confirmed by brain MRI * Markedly reduced or normal signal in the ventral striatum on TRO-DaT SPECT imaging. * Any abnormal findings on brain MRI. * Positive GBA mutation test. * Diagnosis of dementia based on a MoCA score \< 24. * The abnormality of thrombotic system or high risk of bleeding * Positive for any of the following viral markers or active infections: HBsAg, HBsAb, HBcAb, anti-HIV antibodies, anti-HTLV-1\&2 antibodies, active hepatitis C infection, syphilis, or active CMV, VZV, EBV, or COVID-19 infection. * Impossibility of MRI imaging for patients with metal in the body, pacemaker in the body, claustrophobia, with artificial heart valves that are incompatible with MRI or body weight is not within the tolerable range for MRI. * Patients with contraindications to the study drug: Tacrolimus, Prednisolone, Basiliximab, Cotrimoxazole, MRI contrast agent. * Patients undergoing other cell transplants, including embryonic stem cell-derived dopaminergic progenitor cells. * Patients with a history of PD at the same time and concurrent: Malignant neoplasm, epilepsy, cerebral hemorrhage or a positive history * Psychiatric disorders confirmed by a psychiatrist, including major depression, bipolar disorder, or schizophrenia, that are uncontrolled or treatment resistant. * Patients with intellectual disability who, in the judgment of a psychiatrist, are unable to fully comprehend the study requirements. * History of pallidotomy, thalamotomy, or deep brain stimulation (DBS). * Patients considered high-risk candidates for surgery, particularly neurosurgery or DBS implantation, due to significant cardiovascular, pulmonary, or other systemic comorbidities identified during preoperative evaluation. * Patients who have a history of taking the following in the three months prior to enrollment: Immunosuppressant, antipsychotic drug, anticonvulsant drugs or anticoagulant therapy (if discontinuation or perioperative adjustment is not feasible), botulinum toxin (within 6 months), phenol injections, or other treatments for dystonia or muscle spasm * History of Apomorphine use * History of chronic alcohol use or illicit drug abuse. * Patients who are pregnant, lactating, or people who did not avoid pregnancy during the study. * Patients who, according to the researchers' opinions, are not suitable for safe study.

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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

    3 sites. 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

  • Iran University of Medical Sciences

    RECRUITING

    Tehran, Iran

  • Royan Institute

    RECRUITING

    Tehran, Iran

  • Shiraz University of Medical Sciences

    RECRUITING

    Shiraz, Iran

More trials for these conditions

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