RecruitingPhase 1NCT07572071

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

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


Sponsor

Royan Institute

Enrollment

6 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Customized microinjection device, a biological treatment called Dopacell, and others for people with parkinson disease (pd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 30 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDopacell

DopaCells are dopamine-producing progenitor cells generated from human embryonic stem cells through differentiation under GMP-compliant conditions.

DRUGImmunosuppressive Regimen

Basiliximab, Tacrolimus, Prednisolone

DEVICECustomized microinjection device

For intraputaminal delivery of DopaCell


Locations(3)

Shiraz University of Medical Sciences

Shiraz, Iran

Iran University of Medical Sciences

Tehran, Iran

Royan Institute

Tehran, Iran

View Full Details on ClinicalTrials.gov

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NCT07572071


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