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
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
Other study identifiers
Name ANPD001-02
Source weblink
Regulatory body approval
Name Food and Drug Administration (FDA)
United States
Public contact
Public email
United States
Sponsors Aspen Neuroscience


Which differentiated cell type is used
Label dopaminergic neuron
Description A neuron that releases dopamine as a neurotransmitter.


Recruitment Status Enrolling by invitation
Estimated number of participants 9