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

NCT07572071 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Parkinson Disease (PD)

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

Sponsors & Collaborators

  • Royan AtiTech Pharmed

    collaborator UNKNOWN

  • Shiraz University of Medical Sciences

    collaborator OTHER

  • Iran University of Medical Sciences

    collaborator OTHER

  • Royan Institute

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2028-08-01
Completion
2030-08-01

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07572071 on ClinicalTrials.gov