Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- MinYoung Kim, M.D.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Changes in Balance
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in Balance
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Secondary Outcomes
- Changes in Cognition(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Brain structure(Baseline - 12 months)
- Changes in Muscle strength and Spasticity(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Language(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Brain glucose metabolism(Baseline - 12 months)
- Changes in Neural activity(Baseline - 6 months - 12 months)
- Changes in Mobility(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 Activities of Daily Living(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Sensory function(Baseline - 1 month - 3 months - 6 months - 12 months)
- Monitoring Adverse Events(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Visual perception(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Hand function(Baseline - 1 month - 3 months - 6 months - 12 months)