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Allogeneic Umbilical Cord Blood Therapy for Stroke

NCT ID: NCT01884155

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

allogeneic cord blood for stroke patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allogeneic umbilical cord blood therapy

Allogeneic umbilical cord blood therapy

Group Type EXPERIMENTAL

Allogeneic umbilical cord blood therapy

Intervention Type PROCEDURE

Interventions

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Allogeneic umbilical cord blood therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MinYoung Kim, M.D.

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, M.D.

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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MinYoung Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

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CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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UCBStroke

Identifier Type: -

Identifier Source: org_study_id