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A Study of NCS-01 in Patients With Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03915431
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
NC Medial Research Inc

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE February 27, 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
  • National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 1 hour, 3 hours, and 6 hours post infusion ]
    Change from baseline in the NIHSS NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
  • Number of participants with change in in physical examination [ Time Frame: multiple times from baseline through Month 12 ]
    physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
  • Number of participants with change in Electrocardiography (ECG) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    ECG (standard digital 12-lead in singlicate)
  • Number of participants with change in clinical laboratory evaluations [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Number of participants with change in Modified Rankin Scale (mRS) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.Score Description 0 No symptoms at all
    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. Moderate disability; requiring some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. Dead
  • Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    blood test for proteins that modulate the inflammatory response
  • Number of participants with change in MRI [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    global white matter and grey matter volumetrics; cortical thinning on MRI
  • Number of participants with change in Barthel Index [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    Barthel Index is a 4 point scale of Activities of Daily Living
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2019)
  • Number of participants with change in Domain-specific Scales (Gait velocity) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    Gait Velocity is a marker of functional and cognitive status in older adults. Slow gait speed has been associated with poor clinical outcomes such as cognitive decline, falls and hospitalization. Patients with gait speeds of 0.4 to 0.6 m/s, such as those with chronic stroke,20 are considered limited community ambulators.
  • Number of participants with change in Domain-specific Scales (Fugl-Meyer) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
  • Number of participants with change in Domain-specific Scales (Western Aphasia) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    an assessment tool to examine linguistic skills (information content, fluency, auditory comprehension, repetition, naming and word finding, reading, and writing) and main nonlinguistic skills (drawing, block design, calculation, and praxis) of adults with aphasia. The observed language behaviours facilitate diagnosis by classifying the patient as having 1 of 8 types of aphasia (Global, Broca's, Transcortical motor, Wernicke's, Transcortical sensory, Mixed transcortical, Conduction, and Anomic) according to primary aspects of language functioning (Risser & Spreen, 1985). The WAB is also used to determine the location of the lesion.
  • Number of participants with change in Domain-specific (Box and Blocks) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    he Box and Block Test (BBT) measures unilateral gross manual dexterity.
  • Number of participants with change in Domain-specific Scales (Grip strength) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    Muscle strength is rated on a scale of 0/5 to 5/5 as follows: 0/5: no contraction 1/5: muscle flicker, but no movement 2/5: movement possible, but not against gravity (test the joint in its horizontal plane) 3/5: movement possible against gravity, but not against resistance by the examiner 4/5: movement possible against some resistance by the examiner (sometimes this category is subdivided further into 4-/5, 4/5, and 4+/5) 5/5: normal strength
  • Number of participants with change in Domain-specific Scales (Berg Balance) [ Time Frame: multiple times for the duration of the study (baseline through Month 12) ]
    The Berg Balance Scale (BBS) is a 14-item objective measure designed to assess static balance and fall risk in adult populations.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of NCS-01 in Patients With Acute Ischemic Stroke
Official Title  ICMJE A Phase 1/2, Dose-finding, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability of NCS-01 in Patients With Acute Ischemic Stroke
Brief Summary This is an initial Phase1/2 dose-finding, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 24 hours of stroke onset. This study will be conducted in 2 stages.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Biological: NCS-01
    single infusion
  • Biological: Placebo
    single infusion
Study Arms  ICMJE
  • Experimental: NCS-01
    human bone marrow derived cells
    Intervention: Biological: NCS-01
  • Placebo Comparator: Placebo
    placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females, age 18 to 80 years inclusive
  • Clinical evidence of acute ischemic unilateral cerebral infarction
  • - Evidence of neurologic deficits as defined by NIHSS 6 to 18
  • Women of child bearing potential who agrees to take acceptable birth control as described in the ICF
  • Provide written informed consent before participation, either by patient or a legal representative

Exclusion Criteria:

  • Progressive neurologic deficit
  • An inability to undergo an MRI scan
  • Any malignancies within the last 5 years
  • Previous organ transplantation
  • Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months
  • Women of child bearing potential with a positive pregnancy test
  • Already dependent in activities of daily living (Rankin scale 3 or more) before the present acute stroke
  • Known hypersensitivity, allergy or intolerance to the similar biologic interventions
  • Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives judged by Investigator based on medical history, physical examination, laboratory tests and/or ECG
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Martine Francis 301-343-8894 martine@mafinc.com
Contact: Minako Koga 202-615-6004 mkoga@kmphc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915431
Other Study ID Numbers  ICMJE NCS-01-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NC Medial Research Inc
Study Sponsor  ICMJE NC Medial Research Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean Savitz, md The University of Texas Health Science Center, Houston
PRS Account NC Medial Research Inc
Verification Date February 2020

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