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Early testing of a cell transplant for Parkinson’s

Researchers check the safety and practicality of transplanting DopaCell, a cell preparation grown from human embryonic stem cells, into the brain.

Testing a treatment or activity · Study reference: NCT07572071

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2025-08-01
Main measurements finished (planned)
2028-08-01
Study finished (planned)
2030-08-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 30 years to 70 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial

Short title used by the registry

Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease

Original description

Dopason is a phase I, open-label, multicenter, single-arm clinical trial designed to evaluate the safety and feasibility of intraputaminal transplantation of human embryonic stem cell-derived dopaminergic progenitor cells (DopaCells) in patients with moderately severe Parkinson's disease.

Further description from the registry

During this trial phase, a total of six participants will be included and distributed between two clinical centers. Each participant will undergo one standardized surgical procedure consisting of bilateral stereotactic intraputaminal transplantation of approximately 10 × 10⁶ cells in total (about 5 × 10⁶ cells per putamen), aiming to achieve an estimated survival of 200,000 neurons. All procedures will be performed using the same surgical delivery system and an almost identical operative protocol across both sites to ensure procedural consistency. After transplantation, patients will receive immunosuppressive therapy for a duration of one year and will be systematically followed for study outcomes for at least 12 months.

Conditions reported: Parkinson Disease (PD)

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Dopacell; Immunosuppressive Regimen; Customized microinjection device
Phases
PHASE1
Sponsor
Royan Institute
Start date reported by registry
2025-08-01 (actual)

Registry updated: 2026-06-18 · Status last verified by the registry submitter: 2026-06

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Sarvenaz Salahi, MD · 021-23562000 · salahi13639@gmail.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Shiraz University of Medical Sciences

Shiraz, Iran

Recruiting

Sarvenaz Salahi, MD · 021-2356200 · salahi13639@gmail.com

Iran University of Medical Sciences

Tehran, Iran

Recruiting

Sarvenaz Salahi, MD · 021-2356200 · salahi13639@gmail.com

Royan Institute

Tehran, Iran

Recruiting

Sarvenaz Salahi, MD · 021-2356200 · salahi13639@gmail.com

Facility not reported

Iran

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.