Actively Recruiting
Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease
Led by Royan Institute · Updated on 2026-05-07
10
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
R
Royan Institute
Lead Sponsor
R
Royan AtiTech Pharmed
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 70 years
- Diagnosed with Parkinson's disease using MDS clinical Diagnostic Criteria
- Disease duration longer than 5 years
- Moderate Parkinson's disease with Hoehn and Yahr stage 2 or 3 during OFF periods
- Receiving oral medications but symptoms remain inadequately controlled or cause adverse effects
- No history or only mild levodopa-induced dyskinesia with a score of 2 or less on the UDysRS scale
- Clinically meaningful response to therapeutic doses of levodopa
- Laboratory values within required ranges: neutrophils 5000/microliter, platelet count 100,000/microliter, AST/ALT times max normal, total bilirubin 1.5 times max normal, eGFR 3 ml/min/1.73 m2
- Provided informed consent
You will not qualify if you...
- Abnormal immune system function
- Symptomatic brain injuries confirmed by MRI (brain atrophy, infarct, trauma, vascular malformation)
- Markedly reduced or normal ventral striatum signal on TRO-DaT SPECT imaging
- Any abnormal brain MRI findings
- Positive GBA mutation test
- Diagnosis of dementia with MoCA score below 24
- Blood clotting abnormalities or high bleeding risk
- Positive viral infections or markers including hepatitis B, HIV, HTLV, hepatitis C, syphilis, CMV, VZV, EBV, or COVID-19
- Cannot undergo MRI due to metal implants, pacemaker, claustrophobia, incompatible heart valves, or weight limits
- Contraindications to study drugs (Tacrolimus, Prednisolone, Basiliximab, Cotrimoxazole, MRI contrast agent)
- Previous or current participation in other cell transplant trials
- History of certain neurological or psychiatric disorders or intellectual disability
- Prior brain surgeries such as pallidotomy, thalamotomy, or deep brain stimulation
- High surgical risk due to cardiovascular, pulmonary, or systemic conditions
- Recent use of immunosuppressants, antipsychotics, anticonvulsants, anticoagulants, botulinum toxin, phenol injections, or other muscle spasm treatments
- History of Apomorphine use
- History of chronic alcohol or illicit drug abuse
- Pregnant, breastfeeding, or not avoiding pregnancy during the study
- Deemed unsuitable for safe participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royan Institute
Tehran, Iran
Actively Recruiting
Research Team
S
Sarvenaz Salahi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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