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
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