At a glance
ClinicalIndex Comparison Record- ✓Age 18–90 years
- ✓Acute ischemic stroke in MCA distribution demonstrated by MRI DWI or CT with cortical involvement on exam, without clinically significant midline shift
- ✓NIHSS 6–15 (right hemisphere) or 6–20 (left hemisphere) at consent, without >4-point worsening at infusion
- ✓Prior tPA or endovascular reperfusion permitted
- ✕Pre-stroke modified Rankin Scale >1 or pre-existing cognitive deficit
- ✕Clinically significant or symptomatic hemorrhage associated with stroke
- ✕Significant midline shift on CT/MRI, edema, or mass effect increasing risk of neurological decompensation or hemicraniectomy
- ✕Isolated brainstem or pure lacunar stroke
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke - CoBIS 2
In Brief
A Phase 2 clinical trial evaluating Umbilical Cord Blood and Placebo for Stroke and 2 related conditions. Completed, enrolled 79 participants across 6 sites.
Detailed Summary
The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.
Study Details
Timeline
Interventions
Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.