Stroke
Conditions
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.
Interventions
Sponsors
MinYoung Kim, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
allogeneic cord blood for stroke patients
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Balance | Baseline - 1 month - 3 months - 6 months - 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 Mobility | 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 |
| Changes in Language | Baseline - 1 month - 3 months - 6 months - 12 months |
Countries
South Korea
Outcome results
None listed