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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 : Active, not recruiting
First Posted : May 25, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Cyto Therapeutics Pty Limited

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE May 25, 2015
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
  • Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs [ Time Frame: 12 month ]
  • Incidence of on-study adverse events (AEs), serious AEs, related AEs, severe AEs [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT02452723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
  • Worsening of PD based on neurological examinations [ Time Frame: 12 months ]
  • Magnetic Resonance Imaging (MRI) abnormalities [ Time Frame: 12 months ]
  • Electrocardiogram (ECG) readings [ Time Frame: 12 months ]
  • Changes in QUIP (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Biological: ISC-hpNSC
Study Arms  ICMJE Experimental: ISC-hpNSC
Intervention: Biological: ISC-hpNSC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 20, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Syphilis
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02452723
Other Study ID Numbers  ICMJE ISC-hpNSC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cyto Therapeutics Pty Limited
Study Sponsor  ICMJE Cyto Therapeutics Pty Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cyto Therapeutics Pty Limited
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP