About this trial
To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors, CT1-DAP001, into the corpus striatum in patients with Parkinson's disease
Eligibility criteria
Qualifiers
The subject has a diagnosis of PD (clinically established or clinically probable) in accordance with the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015).
The subject has an inadequate response to drug treatments.
The subject is ≥ 40 years and ≤ 75 years of age at the time of informed consent.
The subject has had PD for at least 5 years.
Disqualifiers
The subject has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease.
Atypical parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism).
The subject has clinical indication or diagnosis of abnormal immune function.
The subject has been diagnosed with a major neurocognitive disorder such as dementia, or is high risk for this.
Trial design
Treatments tested in this trial
- Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001)
Treatment groups
Sponsors and collaborators
University of California, San Diego
Lead sponsor
Sumitomo Pharma America, Inc.
Collaborator
Kyoto University
Collaborator
Sumitomo Pharma Co., Ltd.
Collaborator
CiRA Foundation
Collaborator