HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters.

Acute Ischemic Stroke

HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters. The exact precryopreservation nucleated cell content is provided on the container label and accompanying records.

HPC, Cord Blood

BHI Therapeutic Sciences

Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects With Acute Ischemic Stroke

Evaluation of the Safety and Efficacy of HPC, Cord Blood

Number of subjects experiencing any study related Adverse Event (AE) (including clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examination findings) during the 12-month follow-up period

Number of subjects experiencing Graft Versus Host Disease (GVHD) at 12-month follow-up period

The mean change in National Institutes of Health Stroke Scale from baseline to 3 months post-administration

The mean change in National Institutes of Health Stroke Scale from baseline to 6 months post-administration

The mean change in National Institutes of Health Stroke Scale from baseline to 12 months post-administration

The mean change in modified Rankin Score from baseline to 3 months post-administration

The mean change in modified Rankin Score from baseline to 6 months post-administration

The mean change in modified Rankin Score from baseline to 12 months post-administration

The mean change in Barthel Index score from baseline to 3 months post-administration

The mean change in Barthel Index score from baseline to 6 months post-administration

The mean change in Barthel Index score from baseline to 12 months post-administration

Describe changes in infarct volumes from baseline to 3 months post-administration

Describe changes in infarct volumes from baseline to 6 months post-administration

Describe changes in infarct volumes from baseline to 12 months post-administration

Brian Mehling

All subjects in this study will receive an intravenous infusion of ABO/Rh matched umbilical cord blood.

Stroke

Umbilical cord blood units will be selected from a public cord blood bank based on ABO/Rh blood type and cell dose, targeting a range of 0.5 to 5 x 10^7 total nucleated cells per kilogram. The cord blood unit will be intravenously infused into the subject over 5-30 minutes at a rate not exceeding 5 mL/kg/hr. Subjects will not receive immunosuppressive medications or any other cytoreduction prior to infusion.

allogeneic umbilical cord blood

Duke University Medical Center

Houston Methodist

Cord Blood Infusion for Ischemic Stroke

Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke

Number of subjects experiencing any study related Adverse Event (AE) during the 12-month follow-up period

The proportion of subjects experiencing Graft Versus Host Disease (GVHD) at Day 100 post-infusion

The mean change in modified Rankin Score from baseline to 3 months post-infusion

hemoglobinuria/nausea

Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects With Acute Ischemic Stroke

Cord Blood Infusion for Ischemic Stroke

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