This is a phase one study investigating the safety and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Treatment period consisting of 3 sessions of both intravenous infusion and intrathecal injection (or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection). Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 3 months, 6 months and 12 months will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.
The primary objective of the study is to evaluate the safety of HPC, Cord Blood (administered via intravenous infusion and intrathecal injection, or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection) in subjects with acute ischemic stroke. The secondary objective is to evaluate the efficacy of HPC, Cord Blood (as assessed by changes in neurological tests and cerebral infarct volume as measured by diffusion-weighted magnetic resonance imaging (MRI)) in subjects with acute ischemic stroke. This is a prospective, open-label, single-center, exploratory clinical study in subjects ≥ 18 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. All subjects will be administered only ABO- and Rh-matched units of HPC, Cord Blood. Subjects will not be matched for human leukocyte antigen (HLA)-typing. For each administration of HPC, cord blood, the total dose (2.5 × 10\^7 cells/kg; 150 × 10\^7 cells) will be split for intrathecal injection followed immediately by intravenous infusion. HPC, Cord Blood will be administered via intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Intravenous infusion in conjunction with mannitol will be used in instances where a subject is unable to tolerate intrathecal administration. Treatment period consisting of 3 sessions, timed 5 to 12 days apart. Subjects will be monitored for 6 hours post-infusion, and follow up will occur 24 hours after each therapy session. Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 2 weeks, 3 months, 6 months, and 12 months after the first intravenous/intrathecal treatment will include a neurological exam, MRI, and clinical laboratory tests/urinalysis. 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
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.
BHI Therapeutic Sciences
Hackensack, New Jersey, United States
Adverse Events
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
Time frame: 12 months post first administration
Graft Versus Host Disease
Number of subjects experiencing Graft Versus Host Disease (GVHD) at 12-month follow-up period
Time frame: 12 months post first administration
Change in National Institutes of Health Stroke Scale
The mean change in National Institutes of Health Stroke Scale from baseline to 3 months post-administration
Time frame: 3 months post first administration
Change in National Institutes of Health Stroke Scale
The mean change in National Institutes of Health Stroke Scale from baseline to 6 months post-administration
Time frame: 6 months post first administration
Change in National Institutes of Health Stroke Scale
The mean change in National Institutes of Health Stroke Scale from baseline to 12 months post-administration
Time frame: 12 months post first administration
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 3 months post-administration
Time frame: 3 months post first administration
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 6 months post-administration
Time frame: 6 months post first administration
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 12 months post-administration
Time frame: 12 months post first administration
Change in Barthel Index
The mean change in Barthel Index score from baseline to 3 months post-administration
Time frame: 3 months post first administration
Change in Barthel Index
The mean change in Barthel Index score from baseline to 6 months post-administration
Time frame: 6 months post first administration
Change in Barthel Index
The mean change in Barthel Index score from baseline to 12 months post-administration
Time frame: 12 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Describe changes in infarct volumes from baseline to 3 months post-administration
Time frame: 3 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Describe changes in infarct volumes from baseline to 6 months post-administration
Time frame: 6 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Describe changes in infarct volumes from baseline to 12 months post-administration
Time frame: 12 months post first administration
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