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Pilot Investigation of Stem Cells in Stroke (PISCES)

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: NCT01151124
Recruitment Status : Active, not recruiting
First Posted : June 25, 2010
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
ReNeuron Limited

Tracking Information
First Submitted Date  ICMJE June 9, 2010
First Posted Date  ICMJE June 25, 2010
Last Update Posted Date March 10, 2021
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Incidence of adverse events [ Time Frame: 1 year ]
AEs monitored include vital signs, C-reactive protein and full blood count, structural MRI to seek evidence of hemorrhage, new infarction, inflammation or tumor, NIHSS measure (changes greater than 4) to indicate clinically significant neurological deterioration, neurological examination, CTX0E03 antibody screen, changes to concomitant medications
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
  • Barthel Index [ Time Frame: 1 year ]
    Measure of functional outcome (based on activities of daily living)
  • Mini-Mental State Examination [ Time Frame: 1 year ]
    Measure of cognitive impairment
  • modified Rankin Score [ Time Frame: 1 year ]
    Measure of overall disability and handicap
  • EQ-5D [ Time Frame: 1 year ]
    Measure of health-related quality of life outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Investigation of Stem Cells in Stroke
Official Title  ICMJE A Phase I Safety Trial of CTX0E03 Drug Product Delivered Intracranially in the Treatment of Patients With Stable Ischemic Stroke
Brief Summary The study is designed to test the safety of a manufactured neural stem cell line (CTX cells) delivered by injection into the damaged brains of male patients 60 years of age or over who remain moderately to severely disabled 6 months to 5 years following an ischemic stroke. In addition the trial will evaluate a range of potential efficacy measures for future trials. Treatment will involve a single injection of one of four doses of CTX cells into the patient's brain in a carefully controlled neurosurgical operation performed under general anesthetic. The trial is designed to treat 12 patients and measure outcomes over 24 months. Patients will be invited to participate in a long-term follow-up trial for a further 8 years.
Detailed Description

Design: The trial is an open label, single administration, ascending dose, single site trial using CTX neural stem cells with 24-month patient monitoring following treatment.

Pre-treatment selection of patients : Males aged ≥60 years with unilateral ischaemic stroke affecting sub-cortical white matter and/or basal ganglia 6 months to 5 years prior to entry into the study, with persistent unilateral hemiparesis, a minimum infarct diameter of 1 cm and stable neurological functional deficit as determined by the NIH Stroke Scale, (measured twice at least 1 month apart), will be eligible for treatment.

Treatment: The CTX cells will be injected by stereotaxic procedures into the putamen region of the brain of the patient under general anesthesia with imaging guidance to locate injection site. Four ascending doses of CTX cells will be tested in 12 patients (4 dosage groups of three patients at each dose level receiving 2 million, 5 million, 10 million or 20 million cells). Patients will be admitted to hospital the day before surgery and prepared for CTX cell implantation to take place. Patients will be discharged two days after surgery.

One patient will be treated at a time. An independent Data Safety Monitoring Board (DSMB) will make the decision to continue dosing at each dose level following satisfactory review of the 28 day safety data for the first patient at that dose level; and to increase the dose to the next level following satisfactory review of the 3 month safety data for all three patients in the previous dose group.

Post treatment follow-up of patients: There will be 6 scheduled visits to clinic for monitoring and neurofunctional testing and 5 scheduled telephone contacts to monitor adverse events (AEs) and concomitant medications over the 2 year follow-up period.

End-points: The primary end-point of the trial is safety, measured by numbers of relevant Serious Adverse Events, health screening, neurological assessment and scanning abnormalities. The secondary aim is to evaluate various MRI and other test measures for their potential as efficacy markers for subsequent trials.

Post trial follow up: All trial patients will be flagged by the National Health Service Central Register (NHSCR) Scotland for life-long follow-up. In addition, all patients will be invited to take part in an 8-year follow up trial requiring an annual review by a suitable physician.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Biological: CTX0E03 neural stem cells
Single administration by surgical delivery to the damaged area of the brain
Study Arms  ICMJE Experimental: CTX0E03 DP
human neural stem cell product, once only injection, increasing doses
Intervention: Biological: CTX0E03 neural stem cells
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
Estimated Enrollment  ICMJE
 (submitted: June 24, 2010)
12
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males
  • 60 years or over
  • Unilateral ischemic stroke involving subcortical white matter or Basal Ganglia 6 months to 5 years before entry
  • NIHSS score minimum 6 with hemiparesis (2 or more for motor arm and leg)
  • Neurologically stable for 2 m
  • modified Rankin score of 2-4
  • Fit for general anesthesia, neurosurgery
  • Capacity to consent
  • Infarct at least 1cm diameter

Exclusion Criteria:

  • Structural brain vascular lesions requiring surgery or increasing the risk of stereotaxic implantation
  • Unstable medical conditions with expected survival <12 months
  • Any medical condition that would impair participation (eg progressive neurological disorders, mental illness)
  • Major surgery within 30 days
  • Previous allogeneic tissue transplant
  • MMSE < 24
  • Epilepsy
  • Coagulation disorders or anticoagulant treatment that cannot be interrupted
  • Stimulants, botox, tamoxifen
  • Contraindications to MRI
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years to 85 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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01151124
Other Study ID Numbers  ICMJE RN01-CP-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ReNeuron Limited
Study Sponsor  ICMJE ReNeuron Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ReNeuron Limited
Verification Date March 2021

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