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Allogeneic Umbilical Cord Blood Therapy in Children With CP

NCT ID: NCT02025972

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

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-11-15

Brief Summary

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This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic umbilical cord blood therapy for children with cerebral palsy.

Detailed Description

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Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.

Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries.

Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. This study was designed to find cytokines relevant to UCB therapy.

Conditions

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Cerebral Palsy

Keywords

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Cerebral palsy Umbilical cord blood Rehabilitation Cytokine Outcome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

* Diagnosed with cerebral palsy
* Age of ≤15 years
* Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x10\^7/kg. If the cell count is less than given values, more than 1 unit could be used.
* Decision of participation in the study by and acquisition of informed consent from the subject's representative
* Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry

Exclusion Criteria

* Current aspiration pneumonia
* Known genetic disease
* History of hypersensitivity reaction to any study drugs pertinent to the study
* Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
* Uncontrolled hypertension defined as systolic blood pressure \>115 mmHg and/or diastolic blood pressure \>70 mmHg
* Hepatic impairment defined as asparate aminotransferase (AST) \>55 IU/L and/or alanine aminotransferase (ALT) \>45 IU/L
* Renal impairment defined as creatinine (Cr) ≥1.2 mg/dL
* Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
* Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHA University

OTHER

Sponsor Role collaborator

MinYoung Kim, M.D.

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, M.D.

Professor of CHA University, M.D., Ph.D.

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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UCBCP

Identifier Type: -

Identifier Source: org_study_id