Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NCS-01
human bone marrow derived cells
  • Biological: NCS-01
    single infusion
Sham Comparator
sham
sham procedure
  • Biological: NCS-01
    single infusion

Recruiting Locations

The University of Texas
Houston, Texas 77030
Contact:
Mariano Nunez
713-992-7278
mariano.s.nunezr@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
NC Medial Research Inc

Study Contact

Martine Francis
301-343-8894
martine@mafinc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.