We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Allogeneic Umbilical Cord Blood Therapy for Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01884155
First Posted: June 21, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
  Purpose
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.

Condition Intervention Phase
Stroke Procedure: Allogeneic umbilical cord blood therapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
allogeneic cord blood for stroke patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke

Further study details as provided by MinYoung Kim, M.D., Bundang CHA Hospital:

Primary Outcome Measures:
  • Changes in Balance [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]

Secondary Outcome Measures:
  • Changes in Mobility [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Muscle strength and Spasticity [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Activities of Daily Living [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Function of Upper extremity [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Hand function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Visual perception [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Cognition [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Language [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Sensory function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]
  • Changes in Brain structure [ Time Frame: Baseline - 12 months ]
  • Changes in Brain glucose metabolism [ Time Frame: Baseline - 12 months ]
  • Changes in Neural activity [ Time Frame: Baseline - 6 months - 12 months ]
  • Monitoring Adverse Events [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ]

Enrollment: 5
Study Start Date: June 2013
Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic umbilical cord blood therapy
Allogeneic umbilical cord blood therapy
Procedure: Allogeneic umbilical cord blood therapy

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884155


Locations
Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
MinYoung Kim, M.D.
Investigators
Principal Investigator: MinYoung Kim, M.D., Ph.D. CHA University
  More Information

Responsible Party: MinYoung Kim, M.D., Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01884155     History of Changes
Other Study ID Numbers: UCBStroke
First Submitted: June 19, 2013
First Posted: June 21, 2013
Last Update Posted: October 12, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases