Allogeneic Umbilical Cord Blood Therapy for Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01884155
First received: June 19, 2013
Last updated: January 8, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Bundang CHA Hospital:

Primary Outcome Measures:
  • Changes in Balance [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Mobility [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Muscle strength and Spasticity [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Activities of Daily Living [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Function of Upper extremity [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Hand function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Visual perception [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Cognition [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Language [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Sensory function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Brain structure [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
  • Changes in Brain glucose metabolism [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
  • Changes in Neural activity [ Time Frame: Baseline - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Monitoring Adverse Events [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MinYoung Kim, M.D., Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01884155     History of Changes
Other Study ID Numbers: UCBStroke
Study First Received: June 19, 2013
Last Updated: January 8, 2014
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014