A Study of NCS-01 in Patients With Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NCS-01
Sponsored by
![NC Medial Research Inc](https://trials-media.s3.amazonaws.com/orgs/nc-medial-research-inc.jpeg)
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility 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
Sites / Locations
- University of MiamiRecruiting
- The University of TexasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NCS-01
sham
Arm Description
human bone marrow derived cells
sham procedure
Outcomes
Primary Outcome Measures
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
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)
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
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)
ECG (standard digital 12-lead in singlicate)
Number of participants with change in clinical laboratory evaluations
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
Number of participants with change in Modified Rankin Scale (mRS)
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
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead
Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)
blood test for proteins that modulate the inflammatory response
Number of participants with change in MRI
global white matter and grey matter volumetrics; cortical thinning on MRI
Number of participants with change in Barthel Index
Barthel Index is a 4 point scale of Activities of Daily Living
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03915431
Brief Title
A Study of NCS-01 in Patients With Acute Ischemic Stroke
Official Title
A Phase 1/2 Randomized Study to Evaluate the Safety and Tolerability of Intracarotid Artery Administration of NCS-01 in Patients With Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NC Medial Research Inc
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an initial Phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 48 hours of stroke onset. This study will be conducted in 2 stages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NCS-01
Arm Type
Experimental
Arm Description
human bone marrow derived cells
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
sham procedure
Intervention Type
Biological
Intervention Name(s)
NCS-01
Intervention Description
single infusion
Primary Outcome Measure Information:
Title
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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.
Time Frame
1 hour, 3 hours, and 6 hours post infusion
Title
Number of participants with change in in physical examination
Description
physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Time Frame
multiple times from baseline through Month 12
Title
Number of participants with change in Electrocardiography (ECG)
Description
ECG (standard digital 12-lead in singlicate)
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Title
Number of participants with change in clinical laboratory evaluations
Description
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,
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Secondary Outcome Measure Information:
Title
Number of participants with change in Modified Rankin Scale (mRS)
Description
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
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Title
Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)
Description
blood test for proteins that modulate the inflammatory response
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Title
Number of participants with change in MRI
Description
global white matter and grey matter volumetrics; cortical thinning on MRI
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Title
Number of participants with change in Barthel Index
Description
Barthel Index is a 4 point scale of Activities of Daily Living
Time Frame
multiple times for the duration of the study (baseline through Month 12)
Other Pre-specified Outcome Measures:
Title
Number of participants with change in Domain-specific Scales (Fugl-Meyer)
Description
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.
Time Frame
multiple times for the duration of the study (baseline through Month 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females, age 18 to 85 years inclusive
Clinical evidence of acute ischemic unilateral cerebral infarction
- Evidence of neurologic deficits as defined by NIHSS 6 to 18 or NIHSS < 6 with Fugl-Meyer upper extremity subtotal 6 to 40 inclusive
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 childbearing 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine Francis
Phone
301-343-8894
Email
martine@mafinc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Minako Koga
Phone
202-615-6004
Email
mkoga@kmphc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Savitz, md
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Param Kaur, MD
Phone
305-243-2180
Email
pxk325@miami.edu
First Name & Middle Initial & Last Name & Degree
Dileep Yavagal, MD
Facility Name
The University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano Nunez
Phone
713-992-7278
Email
mariano.s.nunezr@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of NCS-01 in Patients With Acute Ischemic Stroke
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