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Trial record 2 of 7 for:    bone marrow and acute stroke and Texas

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

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: NCS-01 Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: NCS-01
human bone marrow derived cells
Biological: NCS-01
single infusion

Placebo Comparator: Placebo
placebo
Biological: Placebo
single infusion




Primary Outcome Measures :
  1. 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;

  2. 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.

  3. 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)

  4. 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)

  5. 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,


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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


  6. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03915431


Contacts
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Contact: Martine Francis 301-343-8894 martine@mafinc.com
Contact: Minako Koga 202-615-6004 mkoga@kmphc.com

Locations
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United States, Texas
The University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Dorothy Parker, RN    713-500-7085    Dorothea.M.Parker@uth.tmc.edu   
Principal Investigator: Anjail Sharrief, MD         
Sponsors and Collaborators
NC Medial Research Inc
Investigators
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Principal Investigator: Sean Savitz, md The University of Texas Health Science Center, Houston
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Responsible Party: NC Medial Research Inc
ClinicalTrials.gov Identifier: NCT03915431    
Other Study ID Numbers: NCS-01-01
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis