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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Duke University Medical Center
Durham, North Carolina, United States
Houston Methodist
Houston, Texas, United States
Adverse Events
Number of subjects experiencing any study related Adverse Event (AE) during the 12-month follow-up period
Time frame: 12 months post-infusion for the last subject
Graft Versus Host Disease
The proportion of subjects experiencing Graft Versus Host Disease (GVHD) at Day 100 post-infusion
Time frame: 100 days
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 3 months post-infusion
Time frame: 3 months post-infusion for the last subject
Change in Infarct Volumes
Describe changes in infarct volumes over the first 3 months post-stroke
Time frame: 3 months post-infusion for the last subject
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.