A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02452723|
Recruitment Status : Unknown
Verified April 2019 by Cyto Therapeutics Pty Limited.
Recruitment status was: Active, not recruiting
First Posted : May 25, 2015
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Biological: ISC-hpNSC||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
- Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs [ Time Frame: 12 month ]
- Change in UPDRS score from baseline [ Time Frame: Baseline and 12 months ]
- Proportion of patients with improvement defined as any reduction in UPDRS motor score [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452723
|Dept of Neurology, The Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|