General Information |
| Summary |
This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects. |
| Description |
Subjects will undergo surgical transplantation of the dopamine-producing cells under general anesthesia into a part of the brain called the putamen. Subjects then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. Safety, tolerability, evidence of cell survival (using MRI and PET scans of the brain), and effect on Parkinson's disease symptoms are assessed for 2 years post-transplant. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2021-05-03 |
| End date (estimated) |
2024-05-31 |
| 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 |
NCT04802733 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04802733 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/study/NCT04802733 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
clinical@bluerocktx.com |
| Public email |
clinical@bluerocktx.com |
| Last name |
BlueRock Therapeutics |
| Phone |
+1 857-777-0512 |
| Country |
|
|
| Sponsors |
BlueRock Therapeutics
|
| 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 |
Active, not recruiting |
| Estimated number of participants |
12 |
