Clinical trial NCT01884155: Allogeneic Umbilical Cord Blood Therapy for Stroke
Official title: Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: allogeneic cord blood for stroke patients
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Balance
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
Secondary outcomes:
measure: Changes in Mobility
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Muscle strength and Spasticity
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Activities of Daily Living
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Function of Upper extremity
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Hand function
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Visual perception
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Cognition
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Language
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Sensory function
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Brain structure
timeFrame: Baseline - 12 months
measure: Changes in Brain glucose metabolism
timeFrame: Baseline - 12 months
measure: Changes in Neural activity
timeFrame: Baseline - 6 months - 12 months
measure: Monitoring Adverse Events
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: MinYoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: