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

Phase 1

Recruiting

• Conditions: Neurological Diseases; Ischemic Stroke; Hemorrhagic Stroke; Cerebral Palsy; Atypical Parkinson Disease
• Interventions: Drug: Combination injection of EPO and G-CSF; Drug: Injection of normal saline

• Registration Number: NCT02018406
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07-05
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Combination injection of EPO and G-CSF	Intervention Group
Control	Injection of normal saline	Control Group

Primary Outcome Measures

Name	Time	Method
Chest and Heart Evaluation	at pre-treatment and 6 months after pretest	(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.
Vital Sign	5th day, 30th day during a cycle, and 6 months after pretest	(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	5th day, 30th day during a cycle, and 6 months after pretest	(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.

Secondary Outcome Measures

Name	Time	Method
Hematological Test	5th day, 30th day during a cycle, and 6 months after pretest	(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.
Occupational Assessment	at pre-treatment, 3 months, and 6 months after pretest	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	at pre-treatment and 6 months after pretest	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	at pre-treatment and 6 months after pretest	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.
Physical Assessment	at pre-treatment, 3 months, and 6 months after pretest	(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.

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of