A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease

General Information
Summary	This study will evaluate the safety of an investigational cell transplantation therapy, ISC-hpNSC, in patients with Parkinson's disease. All patients will receive the therapy, which consists of human neural stem cells. Three dose levels will be examined in the study.
Description	ISC-hpNSC is a cellular therapeutic consisting of human parthenogenetic neural stem cells (hpNSC). ISC-hpNSC will be injected intracerebrally to the striatum and substantia nigra of patients with Parkinson's disease (PD). The study will enroll 4 patients for cell injection at each of three different doses. A total of 12 patients with moderate to severe PD will be treated. Each patient receives a single dose. The main objective of the study is to evaluate the safety of the cell transplantation.
Clinical trials phase	Phase 1
Start date (estimated)	2016-07-01
End date (estimated)	2020-06-30
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].
Publications	Novel Approach to Stem Cell Therapy in Parkinson's Disease Neural Stem Cell Tumorigenicity and Biodistribution Assessment for Phase I Clinical Trial in Parkinson's Disease Neural Stem Cells Derived from Human Parthenogenetic Stem Cells Engraft and Promote Recovery in a Nonhuman Primate Model of Parkinson's Disease
Administrative Information
NCT number	NCT02452723
ICTRP weblink	https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02452723
Other study identifiers	Name ISC-hpNSC
Source weblink	https://www.clinicaltrials.gov/ct2/show/NCT02452723
Study sites	Department of Neurology, The Royal Melbourne Hospital
Public contact	Email Ibrauman@unimelb.edu.au Public email Ibrauman@unimelb.edu.au First name Lisa J. Last name Brauman City Melbourne Country Australia
Sponsors	Cyto Therapeutics Pty Limited
Cells
Which differentiated cell type is used	Label neural stem cell Link http://purl.obolibrary.org/obo/CL_0000047 Description An undifferentiated neural cell that originates from the neuroectoderm and has the capacity both to perpetually self-renew without differentiating and to generate multiple central nervous system neuronal and glial cell types.
Recruitment
Recruitment Status	Active, not recruiting
Estimated number of participants	12
Contact institutions/departments	Department of Neurology, The Royal Melbourne Hospital