A Study of NCS-01 in Patients With Acute Ischemic Stroke
NCT ID: NCT03915431
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2020-02-27
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NCS-01
human bone marrow derived cells
NCS-01
single infusion
sham
sham procedure
NCS-01
single infusion
Interventions
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NCS-01
single infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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NC Medial Research Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sean Savitz, md
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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NCS-01-01
Identifier Type: -
Identifier Source: org_study_id
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