Penelope J. Hallett, Ph.D.
This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell (iPSC)-derived dopamine neurons. This research study is a single-center Phase 1/2a clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease.
The goal of this research study is to test a new treatment for Parkinson's disease. Parkinson's disease is a progressive disease that causes people to lose specific brain cells called midbrain dopamine neurons. When these dopamine neurons are lost, it leads to a lack of dopamine in the brain. When there is not enough dopamine, people with Parkinson's disease experience problems with their movement. This trial will test whether new dopamine neurons made from blood cells from subjects with Parkinson's disease are safe when surgically injected into the area of the brain affected (called the putam…
Inclusion Criteria: * 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 s…
The autologous midbrain dopamine neurons are an experimental cryopreserved cell product derived from human autologous induced pluripotent stem cells. The autologous midbrain dopamine neurons are surgically administered into the putamen. Six participants received unilateral transplantation into one putamen. Six participants will receive bilateral transplantation into both putamina during a single surgical session.
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