NCT06422208
Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease
Enrolling by Invitation
PHASE1Ages 55–80InterventionalTreatmentPenelope J. Hallett, Ph.D.Investigator-initiated
~6 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:Autologous midbrain dopamine neurons
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: number and severity of adverse events and serious adverse events
Measured over Baseline to 12 months post-transplant and baseline to 18 months post-transplant
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Males and females between ages 55 to eighty.
Diagnosis of Parkinson's disease with motor symptoms by neurologist according to Movement Disorder Society (MDS) 2015 Clinical Diagnostic Criteria for Parkinson's disease.
Diagnosis of Parkinson's disease for at least 5 years.
Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale.
No gross abnormalities on MRI, including hydrocephalus or extensive white matter disease.
No significant cognitive impairment (Montreal Cognitive Assessment).
No significant untreated depression (Beck Depression Inventory 2).
Up to date cancer screening per primary MD.
Able to understand trial requirements and intervention procedures and provide written informed consent.
Exclusion
History of intracranial surgeries.
Any previous thalamotomy, pallidotomy or deep brain stimulation.
Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism)
History of psychiatric disorders including schizophrenia or psychosis likely to compromise with ability to comply with trial protocol requirements.
Prior history of intracerebral, subdural, or epidural hemorrhage.
History of malignancy within 5 years.
Inability to have an MRI.
Life expectancy \< 6 months due to concomitant illnesses.
Ingestion of investigational drug or recipient of investigational procedure within 6 months prior to trial.
Subjects with active cardiovascular and cerebrovascular disease within 6 months prior to signing the informed consent form:
Hypertensive subjects with poorly controlled blood pressure (defined as blood pressure above 160/100 mmHg despite treatment with antihypertensive drugs) and subjects with severe postural hypotension.
Abnormal pre-operative coagulation labs.
Any necessary chronic anticoagulation medication in use (not including antiplatelet therapy and chronic NSAID).
Diabetic subjects with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1 mmol/L).
Active infectious disease. Subjects known to have tested positive for HIV, Human T-lymphotropic Virus, Hepatitis B Virus, Hepatitis C Virus, Cytomegalovirus (IgM \> IgG) and/or syphilis will be evaluated by an expert as to subject eligibility based on the subject's infectious status.
Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise subject safety, or interfere with the interpretation of the trial results.
Active clinical infection being treated by antibiotics within one week of enrollment.
Known drug or alcohol dependence or any other clinical factors or conditions (for example, history of seizures) which will interfere with the trial conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
Unwilling and/or not able to give written informed consent.
What this trial measures
- Safety: number and severity of adverse events and serious adverse eventsBaseline to 12 months post-transplant and baseline to 18 months post-transplant
To assess the safety of autologous transplantation of cryopreserved midbrain dopamine neurons into the putamen of subjects with Parkinson's disease by measuring (1) the incidence of serious adverse events at 12 months and 18 months post-transplantation and (2) the incidence and severity of all intervention emergent adverse events.