ClinicalTrials.gov

History of Changes for Study: NCT02452723
A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease
Latest version (submitted April 3, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 20, 2015 None (earliest Version on record)
2 February 10, 2016 Study Status and Oversight
3 March 10, 2016 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Eligibility and Oversight
4 July 19, 2017 Study Status
5 August 21, 2017 Contacts/Locations and Study Status
6 July 18, 2018 Study Status
7 April 3, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02452723
Submitted Date:  May 20, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: ISC-hpNSC
Brief Title: A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2015
Overall Status: Not yet recruiting
Study Start: July 2015
Primary Completion: July 2016 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: May 18, 2015
First Submitted that
Met QC Criteria:
May 20, 2015
First Posted: May 25, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 20, 2015
Last Update Posted: May 25, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cyto Therapeutics Pty Limited
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed 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.

Open or close this module Conditions
Conditions: Parkinson Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ISC-hpNSC Biological: ISC-hpNSC
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs
[ Time Frame: 12 month ]

2. Incidence of on-study adverse events (AEs), serious AEs, related AEs, severe AEs
[ Time Frame: 12 months ]

Secondary Outcome Measures:
1. Worsening of PD based on neurological examinations
[ Time Frame: 12 months ]

2. Magnetic Resonance Imaging (MRI) abnormalities
[ Time Frame: 12 months ]

3. Electrocardiogram (ECG) readings
[ Time Frame: 12 months ]

4. Changes in QUIP (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease
[ Time Frame: 12 months ]

Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Signed informed consent form (ICF) indicating the patient has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
  • Patient diagnosed with idiopathic PD of ≤ 13 years duration, as defined by the United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria
  • Outpatients (male and female) 30 - 70 years old. Females must be of non-child bearing potential, or with a negative pregnancy test and not breast-feeding
  • Patients receiving a stable dose of levodopa for at least 3 months with the expectation that the treatment will remain unchanged throughout the course of the patient's participation in the trial
  • Patients receiving an anti-parkinsonian treatment at a stable dose for at least 3 months with the expectation that the treatment will remain unchanged throughout the course of the patient's participation in the trial
  • Hoehn and Yahr stage II-IV during "ON" time
  • Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) in the "OFF" state ≤ 49
  • Positive dopaminergic response of ≥ 33% decrease in UPDRS motor scores between "OFF" and "ON" states at screening, and unequivocal clinical off periods
  • Patient is experiencing motor fluctuations with at least two cumulative hours of daily "OFF" -time during the waking period, which is measured on at least two consecutive days
  • History of anti-parkinsonian treatment with sufficient doses of levodopa
  • Stable, well-controlled concomitant disorders that would not contraindicate general anesthesia or stereotactic neurosurgery
  • No abnormalities on baseline brain MRI
  • Insufficient control of PD symptoms or intolerable side effects with optimized oral PD therapy
  • Montreal Cognitive Assessment (MOCA) score ≥ 26
  • Willing to fully comply with all study procedures and requirements of the trial
  • No surgery for PD or been treated with neuroleptics in the past 6 months except low-dose quetiapine fumarate or clozapine
  • No significant further improvement with physical therapy/rehabilitation

Exclusion Criteria:

  • Mild cognitive impairment of dementia (MOCA score < 26)
  • The extent or severity of the disease is not measurable
  • Severe dyskinesia in the "OFF" or "ON" states (violent dyskinesias, incompatible with any normal motor task)
  • Pre-existing medical conditions such as bleeding disorders, septicemia, major cardiovascular, cerebrovascular or psychiatric disease
  • Any current or relevant previous history of serious, severe or unstable physical or psychiatric illness or medical disorder that may make the participant unlikely to fully complete the study (depression, anxiety, cognitive impairment or impulse control disorder)
  • Clinically significant abnormal hematologic evaluation (blood count, partial thromboplastin time (PTT)), blood chemistry (glucose, blood urea nitrogen (BUN), creatinine, electrolytes), liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGTP), total protein, bilirubin)
  • Any active infectious disease of any nature, including clinically active viral infections (seropositive for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) and Venereal Disease Research Laboratory (VDRL)
  • Severe obesity
  • Previous intracranial surgery, including deep-brain stimulation
  • History of seizures
  • Substance abuse (recent history of alcohol abuse or other drugs such as barbiturates, cannabinoids and amphetamines)
  • Use of anti-platelet agents or other anti-coagulants
  • Signs of any malignant disease
  • Any use of immunosuppressive drugs
  • Enrollment in other investigational drug trial or has completed any trial within the last 3 months
  • Patients that cannot undergo MRI or PET scanning (i.e. patients with implanted pacemakers)
  • Patients unable to travel to the PET scanning center
  • Any other condition which clinician regards as making patient unsuitable for trial
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services