General Information |
| Summary |
This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells. |
| Description |
Participants will undergo a surgical implantation of cells that will mature into dopamine-producing neurons under general anesthesia into a part of the brain where dopamine production is decreased in patients with Parkinson Disease. The effect on Parkinson Disease symptoms, safety and tolerability, and cell survival are assessed for 5 years post-transplant (with MRI and PET imaging scans of the brain). Safety and tolerability are assessed annually for an additional 10 years via telephone call (total follow-up of 15 years) |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2024-01-23 |
| End date (estimated) |
2030-04-30 |
| 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 |
NCT06344026 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06344026 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06344026 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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| Public contact |
| Email |
info@aspenneuro.com |
| Public email |
info@aspenneuro.com |
| Country |
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| Sponsors |
Aspen Neuroscience
|
| 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 |
Enrolling by invitation |
| Estimated number of participants |
9 |
