Cord Blood Infusion for Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase one study investigating the safety of a single, intravenous infusion of
      banked allogeneic umbilical cord blood in subjects following an acute ischemic stroke. The
      cord blood infusion must be given within 3-10 days of the stroke. Follow up phone calls will
      occur at 1, 6, and 12 months post-infusion, and will include telephone surveys on post-stroke
      rehabilitation and functioning. A follow up clinic visit at 90 days will include a
      neurological exam, MRI, and blood tests.
    

Detailed description: 
      The purpose of this study is to assess the safety of a single, intravenous infusion of banked
      allogeneic umbilical cord blood in subjects within 3-10 days following an acute ischemic
      stroke. The subjects will not be pre-treated with immunosuppressive agents. The primary
      objective is safety assessment and the secondary objectives are to determine which outcome
      measures can be used as primary and secondary endpoints for future randomized Phase 2
      clinical trials, and to describe clinical responses, if any. All subjects will receive
      standard of care acute and rehabilitation treatments while enrolled in this study.

      This is a multicenter Phase 1 safety study in patients 18-80 years of age who have sustained
      a recent ischemic stroke. A total of 10 subjects will be enrolled. Subjects will be given a
      series of baseline neurological assessments, blood tests, and MRI. 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/kg. Umbilical cord blood will be
      administered intravenously as a single infusion between 3 and 10 days post-stroke. Subjects
      will be monitored for 6 hours post-infusion, and follow up will occur 24 hours later.
      Subsequent follow up phone calls will occur at 1, 6, and 12 months, and will include
      telephone surveys on post-stroke rehabilitation and functioning. A follow up clinic visit at
      90 days will include a neurological exam, MRI, and blood tests.

      Risks of cord blood infusion include infusion-related reactions such as anaphylaxis,
      urticaria, dyspnea, hypoxia, cough, wheezing, bronchospasm, nausea, vomiting, hives, fever,
      hypertension, hypotension, bradycardia, tachycardia, rigors, chills, infection, and
      hemoglobinuria. Less likely, long-term risks include transmission of infection or Graft vs
      Host Disease.
    

Intervention name(s): allogeneic umbilical cord blood
Intervention type(s): Biological
Intervention description(s): 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.
Other intervention name(s): cord blood; umbilical cord blood
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; cord blood; umbilical cord blood; hematopoietic stem cells; acute ischemic stroke