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

NCT02018406 | Unknown Phase 1

• 1 other identifier: 4-2010-0468
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Hematological Test

  5th day, 30th day during a cycle, and 6 months after pretest

• Physical Assessment

  at pre-treatment, 3 months, and 6 months after pretest

• Occupational Assessment

  at pre-treatment, 3 months, and 6 months after pretest

• Psychological Assessment

  at pre-treatment and 6 months after pretest

• Verbal Assessment

  at pre-treatment and 6 months after pretest

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention Group

Drug: Combination injection of EPO and G-CSF

Control

PLACEBO COMPARATOR

Control Group

Drug: Injection of normal saline

Interventions

Combination injection of EPO and G-CSF DRUG

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

Injection of normal saline DRUG

Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 20610036 BACKGROUND

• 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.

  PMID: 17885687 BACKGROUND

• 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.

  PMID: 23394350 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Cerebral Palsy; Parkinson Disease, Familial, Type 1

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Sung-Rae Cho, MD

CONTACT

82-2-2228-3715; srcho918@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 23, 2013
• Study Start: July 5, 2011
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

KR (1)