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Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders

NCT ID: NCT02236065

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

2014-08-31

Study Completion Date

2016-07-31

Brief Summary

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This open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor (G-CSF) for patients with brain injury or neurodegenerative disorders.

Detailed Description

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Current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as restorative approach for such disorders.

Conditions

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Brain Injury Cerebral Palsy Amyotrophic Lateral Sclerosis Parkinson's Disease

Keywords

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Umbilical cord blood Granulocyte-colony stimulating factor Brain injury Neurodegenerative disorder Efficacy Safety

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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UCB + G-CSF

UCB + G-CSF

Group Type EXPERIMENTAL

Umbilical cord blood therapy

Intervention Type PROCEDURE

Filgrastim

Intervention Type BIOLOGICAL

Interventions

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Umbilical cord blood therapy

Intervention Type PROCEDURE

Filgrastim

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Brain injury: onset duration over 12 months, Age: 19 years or over
* Cerebral palsy: spastic, dyskinetic or ataxic, Age: 19 years or over
* Parkinson's disease: modified Hoehn and Yahr stage 2.5, 3, 4, Age: 30 to 75 years
* ALS: definite of possible ALS, progression during the past 6 months, Age: 19 to 65

Exclusion Criteria

* Uncontrolled pulmonary, renal dysfunction at enrollment
* Uncontrolled seizure
* Malignant cancer
* Possibility of hypersensitivity to drugs used in this study
* Contraindication to the study intervention or assessment
* Pregnant or breast feeding women
* Non-compliance with the study visits specified in the protocol
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

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

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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UCBnG-CSF

Identifier Type: -

Identifier Source: org_study_id