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
Sponsors	Aspen Neuroscience
Collaborators	California Institute for Regenerative Medicine
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