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

Summary

Participation Requirements

Description

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 se...

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.

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