Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease
ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-70
SponsorRoyan Institute
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
The abnormal function of immune system
The symptomatic brain injuries (brain atrophy, cerebral Infarct, trauma, vascular malformation) confirmed by brain MRI
Markedly reduced or normal signal in the ventral striatum on TRO-DaT SPECT imaging.
Any abnormal findings on brain MRI.
Trial design
Treatments tested in this trial
- Dopacell
- Immunosuppressive Regimen
- Customized microinjection device
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Royan Institute
Lead sponsor
Royan AtiTech Pharmed
Collaborator
Shiraz University of Medical Sciences
Collaborator
Iran University of Medical Sciences
Collaborator
Source ClinicalTrials.gov