General Information |
| Summary |
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 clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease. |
| Description |
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 putamen) of the same subjects (called autologous transplantation). The trial will assess the safety of the injected cells and will also measure the effects of the transplanted autologous dopamine neurons on Parkinson's disease symptoms. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2024-06-01 |
| End date (estimated) |
2027-08-31 |
| 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 |
NCT06422208 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06422208 |
| Other study identifiers |
| Name |
U01NS109463 |
| Description |
U.S. NIH Grant/Contract |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06422208 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
Neurosurgerycrc@bwh.harvard.edu |
| Public email |
Neurosurgerycrc@bwh.harvard.edu |
| First name |
Penelope |
| Last name |
Hallett |
| Phone |
+1 617-732-6564 |
| City |
Boston |
| Country |
|
| Address freetext |
115 Mill St, Belmont, MA 02478, Vereinigte Staaten |
|
| Sponsors |
Penelope J. Hallett, Ph.D.
|
| 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 |
Not yet recruiting |
| Estimated number of participants |
6 |
