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RECRUITING
NCT07572071
PHASE1

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

Sponsor: Royan Institute

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

30 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-08-01

Completion Date

2030-08-01

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

Dopacell

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

DRUG

Immunosuppressive Regimen

Basiliximab, Tacrolimus, Prednisolone

DEVICE

Customized 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