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Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury

Primary Purpose

Neurological Diseases, Ischemic Stroke, Hemorrhagic Stroke

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Combination injection of EPO and G-CSF
Injection of normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurological Diseases focused on measuring Hematopoietic Growth Factors (EPO, G-CSF),, Neurological Diseases,, Neurorehabilitation,, Neurotrophic and Neuroprotective Effects

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 20 years old
  • Voluntary participants
  • Neurological diseases including stroke, cerebral palsy, or atypical parkinsonism, at least 3 months after their onset
  • Participants who got previous EPO+GCSF injection at least 6 months ago.

Exclusion Criteria:

  • Under 20 years old
  • Participants who can not voluntarily consent
  • Encephalopathy including brain tumor and infection
  • Warfarin (coumadin) medications
  • Leukopenia, Thrombocytopenia, Polycythemia
  • Malignant diseases, Malignant hypertension, Myeloproliferative disorder, Septic embolism, Hyperkalemia
  • Hepatic or Renal dysfunction, Serum creatinine>3mg/dl
  • Allergic reactions against to exogenous EPO and G-CSF
  • Involved in a exclusion criteria for MRI test
  • A women who is pregnant or on breast feeding
  • Body temperature over 38°C
  • Blood pressure over 140/90 mmHg at pre-treatment
  • Blood pressure over 160/100 mmHg during intervention
  • Hb > 15 g/dL at pre-treatment
  • Hb > 17 g/dL during intervention
  • Pneumonia detected by X-ray test
  • Recurrent history of aspiration pneumonia

Sites / Locations

  • Department of Rehabilitation Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Intervention Group

Control Group

Outcomes

Primary Outcome Measures

Vital Sign
(1) Value of Systolic and Diastolic Blood Pressure, (2) Value of Pulse Rate, (3) Value of Respiratory Rate, (4) Value of Body Temperature. Vital Sign is tested to confirm the safety of the combination of EPO and G-CSF.
Hematological Test
(1) Value of Complete Blood Cells at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (2) Value of Reticulocyte at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (3) Value of Erythrocyte Sedimentation Rate at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (4) Value of C-Reactive Protein at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (5) Value of Electrolyte and Routine Chemistry at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (6) Value of Prothrombin Time and Activated Partial Thromboplastin Time at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest. Hematological Test is tested to confirm the safety of the combination of EPO and G-CSF.
Chest and Heart Evaluation
(1) Chest X-ray finding at pre-treatment and 6 months after pretest, (2) Electrocardiography finding at pre-treatment and 6 months after pretest. Chest and Heart Evaluation is tested to confirm the safety of the combination of EPO and G-CSF.

Secondary Outcome Measures

Hematological Test
(1) Value of Erythropoietin Level, (2) Value of CD34+ cells. Value of Erythropoietin Level and CD 34+ Cells are tested to demonstrate the hematological changes and effectiveness of the combination of EPO and G-CSF.
Physical Assessment
(1) Score of Muscle Strength with Manual Muscle Testing, (2) Score of Joint Mobility with Range of Motion Test, (3) Score of Muscle Spasticity with Modified Ashworth Scale. Physical Assessment is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Occupational Assessment
Score of Activities of Daily Living with Modified Barthel Index, Functional Independence Measure. Occupational Assessments is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Psychological Assessment
Score of Psychological Status with Mini-Mental Status Examination, Memory Quotient, Geriatric Depression Scale, if necessary Psychological Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Verbal Assessment
Score of Verbal Function with Aphasia Quotient, Boston Naming Test, Multi-dimensional Voice Performance, if necessary. Verbal Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.

Full Information

First Posted
October 30, 2013
Last Updated
December 23, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02018406
Brief Title
Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2011 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of our study is to determine the safety and efficacy of the combination of erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with neurological diseases. To be specific, our clinical study is expected that the combination injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating endogenous repair process in patients with neurological diseases including stroke, cerebral palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique in patients with neurological diseases, which is expected to overcome current ethical and technical limitations of less evidenced functional recovery, hematological changes, and side effects. Eventually, We will establish a comprehensive clinical background about neurotrophic and neuroprotective effects of this hematopoietic growth factors therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Diseases, Ischemic Stroke, Hemorrhagic Stroke, Cerebral Palsy, Atypical Parkinson Disease
Keywords
Hematopoietic Growth Factors (EPO, G-CSF),, Neurological Diseases,, Neurorehabilitation,, Neurotrophic and Neuroprotective Effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention Group
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control Group
Intervention Type
Drug
Intervention Name(s)
Combination injection of EPO and G-CSF
Intervention Description
Subcutaneous EPO(300 U/kg)+G-CSF(10 μg/kg) injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Intervention Type
Drug
Intervention Name(s)
Injection of normal saline
Intervention Description
Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Primary Outcome Measure Information:
Title
Vital Sign
Description
(1) Value of Systolic and Diastolic Blood Pressure, (2) Value of Pulse Rate, (3) Value of Respiratory Rate, (4) Value of Body Temperature. Vital Sign is tested to confirm the safety of the combination of EPO and G-CSF.
Time Frame
5th day, 30th day during a cycle, and 6 months after pretest
Title
Hematological Test
Description
(1) Value of Complete Blood Cells at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (2) Value of Reticulocyte at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (3) Value of Erythrocyte Sedimentation Rate at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (4) Value of C-Reactive Protein at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (5) Value of Electrolyte and Routine Chemistry at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (6) Value of Prothrombin Time and Activated Partial Thromboplastin Time at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest. Hematological Test is tested to confirm the safety of the combination of EPO and G-CSF.
Time Frame
5th day, 30th day during a cycle, and 6 months after pretest
Title
Chest and Heart Evaluation
Description
(1) Chest X-ray finding at pre-treatment and 6 months after pretest, (2) Electrocardiography finding at pre-treatment and 6 months after pretest. Chest and Heart Evaluation is tested to confirm the safety of the combination of EPO and G-CSF.
Time Frame
at pre-treatment and 6 months after pretest
Secondary Outcome Measure Information:
Title
Hematological Test
Description
(1) Value of Erythropoietin Level, (2) Value of CD34+ cells. Value of Erythropoietin Level and CD 34+ Cells are tested to demonstrate the hematological changes and effectiveness of the combination of EPO and G-CSF.
Time Frame
5th day, 30th day during a cycle, and 6 months after pretest
Title
Physical Assessment
Description
(1) Score of Muscle Strength with Manual Muscle Testing, (2) Score of Joint Mobility with Range of Motion Test, (3) Score of Muscle Spasticity with Modified Ashworth Scale. Physical Assessment is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Time Frame
at pre-treatment, 3 months, and 6 months after pretest
Title
Occupational Assessment
Description
Score of Activities of Daily Living with Modified Barthel Index, Functional Independence Measure. Occupational Assessments is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Time Frame
at pre-treatment, 3 months, and 6 months after pretest
Title
Psychological Assessment
Description
Score of Psychological Status with Mini-Mental Status Examination, Memory Quotient, Geriatric Depression Scale, if necessary Psychological Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Time Frame
at pre-treatment and 6 months after pretest
Title
Verbal Assessment
Description
Score of Verbal Function with Aphasia Quotient, Boston Naming Test, Multi-dimensional Voice Performance, if necessary. Verbal Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.
Time Frame
at pre-treatment and 6 months after pretest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 20 years old Voluntary participants Neurological diseases including stroke, cerebral palsy, or atypical parkinsonism, at least 3 months after their onset Participants who got previous EPO+GCSF injection at least 6 months ago. Exclusion Criteria: Under 20 years old Participants who can not voluntarily consent Encephalopathy including brain tumor and infection Warfarin (coumadin) medications Leukopenia, Thrombocytopenia, Polycythemia Malignant diseases, Malignant hypertension, Myeloproliferative disorder, Septic embolism, Hyperkalemia Hepatic or Renal dysfunction, Serum creatinine>3mg/dl Allergic reactions against to exogenous EPO and G-CSF Involved in a exclusion criteria for MRI test A women who is pregnant or on breast feeding Body temperature over 38°C Blood pressure over 140/90 mmHg at pre-treatment Blood pressure over 160/100 mmHg during intervention Hb > 15 g/dL at pre-treatment Hb > 17 g/dL during intervention Pneumonia detected by X-ray test Recurrent history of aspiration pneumonia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Rae Cho, MD
Phone
82-2-2228-3715
Email
srcho918@yuhs.ac
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Rae Cho, MD
Phone
82-2-2228-3715
Email
srcho918@yuhs.ac

12. IPD Sharing Statement

Citations:
PubMed Identifier
20610036
Citation
Im SH, Yu JH, Park ES, Lee JE, Kim HO, Park KI, Kim GW, Park CI, Cho SR. Induction of striatal neurogenesis enhances functional recovery in an adult animal model of neonatal hypoxic-ischemic brain injury. Neuroscience. 2010 Aug 11;169(1):259-68. doi: 10.1016/j.neuroscience.2010.04.038.
Results Reference
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PubMed Identifier
17885687
Citation
Cho SR, Benraiss A, Chmielnicki E, Samdani A, Economides A, Goldman SA. Induction of neostriatal neurogenesis slows disease progression in a transgenic murine model of Huntington disease. J Clin Invest. 2007 Oct;117(10):2889-902. doi: 10.1172/JCI31778.
Results Reference
background
PubMed Identifier
23394350
Citation
Seo JH, Kim H, Park ES, Lee JE, Kim DW, Kim HO, Im SH, Yu JH, Kim JY, Lee MY, Kim CH, Cho SR. Environmental enrichment synergistically improves functional recovery by transplanted adipose stem cells in chronic hypoxic-ischemic brain injury. Cell Transplant. 2013;22(9):1553-68. doi: 10.3727/096368912X662390. Epub 2013 Feb 4.
Results Reference
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Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury

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