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].

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
Public contact
Email Ibrauman@unimelb.edu.au
Public email Ibrauman@unimelb.edu.au
First name Lisa J.
Last name Brauman
City Melbourne
Sponsors Cyto Therapeutics Pty Limited


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 Status Active, not recruiting
Estimated number of participants 12
Contact institutions/departments