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/NCIT_C26845
Description A progressive degenerative disorder of the central nervous system characterized by loss of dopamine producing neurons in the substantia nigra and the presence of Lewy bodies in the substantia nigra and locus coeruleus. Signs and symptoms include tremor which is most pronounced during rest, muscle rigidity, slowing of the voluntary movements, a tendency to fall back, and a mask-like facial expression.
Publications

Administrative Information

NCT number NCT02452723
ICTRP weblink http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02452723
Other study identifiers
Name ISC-hpNSC
Source weblink https://www.clinicaltrials.gov/ct2/show/NCT02452723
Regulatory body approval
Country
Study sites
Public contact
Email Ibrauman@unimelb.edu.au
Public email Ibrauman@unimelb.edu.au
First name Lisa J.
Last name Braumen
City Melbourne
Country
Australia
Sponsors Cyto Therapeutics Pty Limited

Cell Line

Recruitment

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