Allogeneic Umbilical Cord Blood Therapy for Stroke

Completed

Phase 1 Results N/A

Trial Description

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.

Detailed Description

Stroke is one of the most common etiologies causing disability in developed countries. There remains no proven treatments except tissue plasminogen activator currently. Based on promising results of cell therapy in animal stroke models, efforts to apply cell therapy for patients with stroke has been made. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for stroke.

Conditions

Interventions

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in Balance Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Mobility Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Muscle strength and Spasticity Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Activities of Daily Living Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Function of Upper extremity Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Hand function Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Visual perception Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Cognition Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Language Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Sensory function Baseline - 1 month - 3 months - 6 months - 12 months No
Secondary Changes in Brain structure Baseline - 12 months No
Secondary Changes in Brain glucose metabolism Baseline - 12 months No
Secondary Changes in Neural activity Baseline - 6 months - 12 months No
Secondary Monitoring Adverse Events Baseline - 1 month - 3 months - 6 months - 12 months Yes

Sponsors