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NCT03915431 | Recruiting | Ischemic Stroke

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

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

Ischemic Stroke

Intervention/treatment

NCS-01

Placebo

Phase

Phase 1

Phase 2

Study Type : Interventional
Estimated Enrollment : 16 participants
Masking: Quadruple
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 2023
Estimated Study Completion Date : October 2024
Arm Intervention/treatment

Experimental: NCS-01

human bone marrow derived cells

Biological: NCS-01

Placebo Comparator: Placebo

placebo

Biological: Placebo
Ages Eligible for Study: 18 Years to 80 Years
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
A Study of NCS-01 in Patients With Acute Ischemic Stroke

Location Details

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

How to Participate

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Locations

Recruiting

United States, Texas

The University of Texas

Houston, Texas, United States, 77030