Phase 1/​2a Study of ANPD001 in Parkinson Disease (ASPERO)

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	Name ANPD001-02
Source weblink	https://clinicaltrials.gov/study/NCT06344026
Regulatory body approval	Name Food and Drug Administration (FDA) Country United States
Public contact	Email info@aspenneuro.com Public email info@aspenneuro.com Country United States
Sponsors	Aspen Neuroscience
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