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

Patients with embolic ischemic stroke or transient ischemic attack of undetermined source

Patients with superior sagittal sinus cerebral venous thrombosis of undetermined source

Paroxysmal Nocturnal Hemoglobinuria

Embolic Stroke of Undetermined Source

Transient Ischemic Attack

Cerebral Vein Thrombosis

London Health Sciences Centre

Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS

Paroxysmal Nocturnal Hemoglobinuria and Embolic Strokes of Undetermined Source (ESUS) and Transient Ischemic Attacks of Undetermined Source (ETUS)

Percentage of patients with flow-cytometry-confirmed PNH

Percentage of ESUS/ETUS patients with flow-cytometry-confirmed PNH

Percentage of SSS-CVTUS patients with flow-cytometry-confirmed PNH

Lawson Health Research Institute

Alexion Pharmaceuticals

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

Describe changes in infarct volumes over the first 3 months post-stroke

Joanne Kurtzberg, MD

Principal Investigator

EMP levels will be measured at ICU admission in subjects with physician-suspected sepsis. For each subject, the final diagnosis of sepsis or non-sepsis critical illness will be adjudicated using standard criteria. The subjects without sepsis will form the Test Cohort.

EMP levels will be measured at ICU admission in subjects with physician-suspected sepsis. For each subject, the final diagnosis of sepsis or non-sepsis critical illness will be adjudicated using standard criteria.The subjects determined to have sepsis will serve as the Validation Cohort .

Systemic Inflammatory Response Syndrome

Weill Cornell Medical College

Hamad Medical Corporation

Endothelial Microparticles as a Biomarker for Diagnosis and Prognosis in Early Sepsis

To evaluate the hypothesis that EMP level is a predictive biomarker for the diagnosis of sepsis. For the primary objective, a prospective, cross-sectional, case control design will be utilized. EMP levels will be measured at ICU admission in subjects with physician-suspected sepsis. For each subject, the final diagnosis of sepsis or non-sepsis critical illness will be adjudicated using standard criteria, and the subjects determined to have sepsis will serve as the cases while those subjects without sepsis will form the control group.

To evaluate the hypothesis that EMP level is a predictive biomarker for mortality in sepsis. For the secondary objective, EMP levels will be measured on admission and daily for the first 5 ICU days or until the subject dies or leaves the ICU. While data will be collected prospectively on all subjects, the cohort for analysis for this objective will include only those subjects with a validated diagnosis of sepsis. In these subjects, 30-day mortality will be ascertained, and EMP levels correlated with mortality to determine the utility of EMPs as a biomarker for mortality risk in sepsis.

hemoglobinuria/mŕtvica

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

Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS

Cord Blood Infusion for Ischemic Stroke

Endothelial Microparticles as a Biomarker for Diagnosis and Prognosis in Early Sepsis

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