Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease (NCT07572071) | Clinical Trial Compass
RecruitingPhase 1
Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease
Iran6 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 syste…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily measuring safety and feasibility of transplanting DopaCell into both sides of the brain, what does that mean about how much we currently know — or don't know — about whether this approach actually improves Parkinson's symptoms?
2The trial involves bilateral striatal transplantation, meaning surgery on both sides of the brain — what are the specific surgical risks I should understand before even considering whether this might be worth discussing further with my care team?
3Are there standard Parkinson's treatments or other options I haven't tried yet that my doctor would recommend exploring before thinking about an experimental cell transplant like this one?
4Since the trial is still in the early safety-testing phase, what kinds of side effects or complications are researchers most concerned about watching for with DopaCell transplantation, and how would those be monitored and managed?
5Given that this trial is actively recruiting, what would the time commitment and follow-up schedule realistically look like for someone who enrolled, and how might that fit around managing my Parkinson's care day to day?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.