Allogeneic Umbilical Cord Blood Therapy for Stroke
- Conditions
- Stroke
- Interventions
- Procedure: Allogeneic umbilical cord blood therapy
- Registration Number
- NCT01884155
- Lead Sponsor
- MinYoung Kim, M.D.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Allogeneic umbilical cord blood therapy Allogeneic umbilical cord blood therapy Allogeneic umbilical cord blood therapy
- Primary Outcome Measures
Name Time Method Changes in Balance Baseline - 1 month - 3 months - 6 months - 12 months
- Secondary Outcome Measures
Name Time Method 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 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 Mobility 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 Brain structure Baseline - 12 months Changes in Hand function Baseline - 1 month - 3 months - 6 months - 12 months
Trial Locations
- Locations (1)
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of