Allogeneic Umbilical Cord Blood Therapy for Stroke

October 10, 2017 updated by: MinYoung Kim, M.D.

Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
        • Cha Bundang Medical Center, Cha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Allogeneic umbilical cord blood therapy
Procedure: Allogeneic umbilical cord blood therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Balance
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in Mobility
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
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
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
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
Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Hand function
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Visual perception
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Cognition
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Language
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Sensory function
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Brain structure
Time Frame: Baseline - 12 months
Baseline - 12 months
Changes in Brain glucose metabolism
Time Frame: Baseline - 12 months
Baseline - 12 months
Changes in Neural activity
Time Frame: Baseline - 6 months - 12 months
Baseline - 6 months - 12 months
Monitoring Adverse Events
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
Baseline - 1 month - 3 months - 6 months - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MinYoung Kim, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (ESTIMATE)

June 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCBStroke

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Allogeneic umbilical cord blood therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe