Allogeneic Umbilical Cord Blood Therapy for Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Allogeneic umbilical cord blood therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or hemorrhagic stroke Onset duration over 12 months Hemisphere lesions except brain stem and cerebellar lesions National Institute Health Stroke Scale: 10 to 15 Exclusion Criteria: Possibility of hypersensitivity drugs used in this study Uncontrolled hypertension or cardiovascualr diseases Malignant cancer Renal or hepatic dysfunction (Consultation to specialist in nephrology or gastroenterology in case of renal or hepatic dysfunction) Severe pulmonary dysfunction Traumatic brain injury Lack of matched UCB
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: allogeneic cord blood for stroke patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic umbilical cord blood therapy<br>Allogeneic umbilical cord blood therapy | Procedure: Allogeneic umbilical cord blood therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Balance |  | Baseline - 1 month - 3 months - 6 months - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mobility |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Muscle strength and Spasticity |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Activities of Daily Living |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Function of Upper extremity |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Hand function |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Visual perception |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Cognition |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Language |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Sensory function |  | Baseline - 1 month - 3 months - 6 months - 12 months | 
| Changes in Brain structure |  | Baseline - 12 months | 
| Changes in Brain glucose metabolism |  | Baseline - 12 months | 
| Changes in Neural activity |  | Baseline - 6 months - 12 months | 
| Monitoring Adverse Events |  | Baseline - 1 month - 3 months - 6 months - 12 months |