Cord Blood Infusion for Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT02397018|
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Biological: allogeneic umbilical cord blood||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||February 23, 2017|
|Actual Study Completion Date :||February 23, 2017|
Experimental: Allogeneic Umbilical Cord Blood Infusion
All subjects in this study will receive an intravenous infusion of ABO/Rh matched umbilical cord blood.
Biological: allogeneic umbilical cord blood
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.
- Adverse Events [ Time Frame: 12 months post-infusion for the last subject ]Number of subjects experiencing any study related Adverse Event (AE) during the 12-month follow-up period
- Graft Versus Host Disease [ Time Frame: 100 days ]The proportion of subjects experiencing Graft Versus Host Disease (GVHD) at Day 100 post-infusion
- Change in modified Rankin Score [ Time Frame: 3 months post-infusion for the last subject ]The mean change in modified Rankin Score from baseline to 3 months post-infusion
- Change in Infarct Volumes [ Time Frame: 3 months post-infusion for the last subject ]Describe changes in infarct volumes over the first 3 months post-stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397018
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Joanne Kurtzberg, M.D.||Duke University|