General Information |
| Summary |
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. |
| Description |
Single-center, open-label, uncontrolled. The primary objective of this study is to evaluate the safety of CT1-DAP001 in subjects with Parkinson's disease by determining the incidence and severity of adverse events, especially graft expansion, after transplantation into the corpus striatum. Other objectives are to evaluate the efficacy of CT1-DAP001 through the assessment of Parkinson's disease symptoms and clinical severity or progression. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2024-06-01 |
| End date (estimated) |
2028-05-01 |
| Clinical feature |
| Label |
Parkinson's disease |
| Link |
http://purl.obolibrary.org/obo/DOID_14330 |
| Description |
A synucleinopathy that has_material_basis_in degeneration of the central nervous system that often impairs motor skills, speech, and other functions.; Xref MGI.
OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT06482268 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06482268 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06482268 |
| Public contact |
| Email |
chfulinara@health.ucsd.edu |
| Public email |
chfulinara@health.ucsd.edu |
| First name |
Christian |
| Last name |
Fulinara |
| Phone |
+1 (858) 2494020 |
| Country |
|
|
| Sponsors |
University of California, San Diego
|
| Collaborators |
|
Cells |
| Which differentiated cell type is used |
| Label |
dopaminergic neuron |
| Link |
http://purl.obolibrary.org/obo/CL_0000700 |
| Description |
A neuron that releases dopamine as a neurotransmitter. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
7 |
