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Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke - CoBIS 2

Primary Objective

The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows: 1.To describe the safety and tolerability of a single IV infusion of unrelated donor UCB in patients with ischemic stroke 2.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement of neurological symptoms following ischemic stroke 3.To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement in quality of life and emotional and cognitive status in patients with ischemic stroke

Study category: Brain and Nervous System

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Details
Age

Adult

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Daniel Vela Duarte

Daniel Vela Duarte

Study ID

Protocol Number: 17-2136

ClinicalTrials.gov: NCT03004976

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