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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Dopacell
Biological/VaccineDopaCells are dopamine-producing progenitor cells generated from human embryonic stem cells through differentiation under GMP-compliant conditions.
Immunosuppressive Regimen
DrugBasiliximab, Tacrolimus, Prednisolone
Customized microinjection device
DeviceFor intraputaminal delivery of DopaCell
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: TransplantationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Safety
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame
Baseline to 12 Months Post-Transplant2
Safety
Evidence of any post-transplantation anatomical changes at the transplant site suggestive of tumor formation, as assessed by MRI imaging.
Time frame
Baseline to 12 Months Post-Transplant3
Feasibility
Successful completion of a single-session intraputaminal transplantation with of the intended cell dose
Time frame
Baseline to 12 Months Post-TransplantSecondary outcomes
1
Efficacy
Changes in the duration of OFF and ON periods following intracerebral DopaCells transplantation as assessed by the Hauser diary
Time frame
Baseline to 12 Months Post-Transplant2
Efficacy
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score from baseline following intracerebral DopaCells transplantation during ON and OFF periods ( MDS-UPDRS Part III ranges from 0 to 132, where higher scores indicate worse motor impairment.)
Time frame
Baseline to 12 Months Post-Transplant3
Efficacy
Graft survival following intracerebral DopaCells transplantation based on TRODAT SPECT imaging findings.
Time frame
Baseline to 12 Months Post-Transplant4
Continuous Safety
Continuous Safety: The number and severity of treatment-emergent adverse events
Time frame
Baseline to 60 Months Post-TransplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Royan Institute
Lead sponsor
Royan AtiTech Pharmed
Collaborator
Shiraz University of Medical Sciences
Collaborator
Iran University of Medical Sciences
Collaborator
Source ClinicalTrials.gov