Back to resultsAllogeneic Umbilical Cord Blood Therapy for Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Allogeneic umbilical cord blood therapy
Sponsored by
About this trial
This is an interventional treatment trial 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
Sites / Locations
- CHA Bundang Medical Center, CHA University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic umbilical cord blood therapy
Arm Description
Allogeneic umbilical cord blood therapy
Outcomes
Primary Outcome Measures
Changes in Balance
Secondary Outcome Measures
Changes in Mobility
Changes in Muscle strength and Spasticity
Changes in Activities of Daily Living
Changes in Function of Upper extremity
Changes in Hand function
Changes in Visual perception
Changes in Cognition
Changes in Language
Changes in Sensory function
Changes in Brain structure
Changes in Brain glucose metabolism
Changes in Neural activity
Monitoring Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01884155
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
MinYoung Kim, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
allogeneic cord blood for stroke patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic umbilical cord blood therapy
Arm Type
Experimental
Arm Description
Allogeneic umbilical cord blood therapy
Intervention Type
Procedure
Intervention Name(s)
Allogeneic umbilical cord blood therapy
Primary Outcome Measure Information:
Title
Changes in Balance
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Secondary Outcome Measure Information:
Title
Changes in Mobility
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Muscle strength and Spasticity
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Activities of Daily Living
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Function of Upper extremity
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Hand function
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Visual perception
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Cognition
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Language
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Sensory function
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in Brain structure
Time Frame
Baseline - 12 months
Title
Changes in Brain glucose metabolism
Time Frame
Baseline - 12 months
Title
Changes in Neural activity
Time Frame
Baseline - 6 months - 12 months
Title
Monitoring Adverse Events
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MinYoung Kim, M.D., Ph.D.
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Allogeneic Umbilical Cord Blood Therapy for Stroke
We'll reach out to this number within 24 hrs