General Information |
| Summary |
The goal of this clinical trial is to assess the safety and tolerability of the surgical transplantation of dopaminergic progenitor cells into the brains of participants with Parkinson's disease. The transplanted dopaminergic cells will be derived from the participant's own skin cells. |
| Description |
This Phase I, open-label clinical trial aims to assess the feasibility and safety of autologous midbrain dopaminergic progenitor cell (mDAP) transplantation for the treatment of Parkinson's disease. mDAPs will be produced for each participant from a fibroblast sample and then transplanted bilaterally into the putamen under general anesthesia. The study will assess the safety and tolerability of the cell transplant procedure through clinical assessments and neuroimaging (CT, MRI and 18F-DOPA PET) over a 2-year follow-up period. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2024-12-01 |
| End date (estimated) |
2028-12-31 |
| 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 |
NCT06687837 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06687837 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06687837 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
jschweitzer1@mgh.harvard.edu |
| Public email |
jschweitzer1@mgh.harvard.edu |
| First name |
Jeffrey S |
| Last name |
Schweitzer |
| Phone |
+1 617 726 1799 |
| City |
Boston |
| Country |
|
| Address freetext |
Massachusetts General Hospital Boston, Massachusetts, United States, 02114 |
|
| Sponsors |
Jeffrey S. Schweitzer, MD, PhD
|
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 |
8 |
