Stereotactic Intracerebral Injection of IPSC-DAPs in Patients with Parkinson's Disease

General Information
Summary	Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.
Description	Patients with Parkinson's disease will be treated with autologous induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.
Clinical trials phase	Phase 1
Start date (estimated)	2025-05-15
End date (estimated)	2026-09-30
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	NCT06821529
ICTRP weblink	https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06821529
Other study identifiers	Name (2025)LSYD(0172)H
Source weblink	https://clinicaltrials.gov/study/NCT06821529
Public contact	Email jialipu@zju.edu.cn Public email jialipu@zju.edu.cn First name Jiali Last name Piu Phone +86 13989468062 Country China Address freetext Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsors	iCamuno Biotherapeutics Ltd
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	Not yet recruiting
Estimated number of participants	12