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

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02018406
• Other study ID #: 4-2010-0468
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 5, 2011
• Est. completion date: December 2025

Study information

• Verified date: December 2020
• Source: Yonsei University
• Contact: Sung-Rae Cho, MD
• Phone: 82-2-2228-3715
• Email: srcho918[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Parkinson Disease
• Cerebral Palsy
• Hemorrhagic Stroke
• Ischemic Stroke
• Nervous System Diseases
• Neurological Diseases
• Parkinson Disease
• Stroke

Intervention

Drug:
• Combination injection of EPO and G-CSF
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.
• Injection of normal saline
Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5th day, 30th day during a cycle, and 6 months after pretest
Primary	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.	5th day, 30th day during a cycle, and 6 months after pretest
Primary	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.	at pre-treatment and 6 months after pretest
Secondary	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.	5th day, 30th day during a cycle, and 6 months after pretest
Secondary	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.	at pre-treatment, 3 months, and 6 months after pretest
Secondary	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.	at pre-treatment, 3 months, and 6 months after pretest
Secondary	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.	at pre-treatment and 6 months after pretest
Secondary	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.	at pre-treatment and 6 months after pretest