Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorUniversity of California, San Diego

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

7 Participants
are divided into 1 treatment group

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