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Neurological DiseasesPhase 1/2NCT02018406

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

A Phase 1/2 study testing Combination injection of EPO and G-CSF and Injection of normal saline in people with Neurological Diseases and Ischemic Stroke, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Combination injection of EPO and G-CSF and Injection of normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSouth Korea
Study dates
5 Jul 2011to Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sung-Rae Cho, MD contact

82-2-2228-3715

srcho918@yuhs.ac

South Korea1 site, 1 recruiting

  • Department of Rehabilitation Medicine, Yonsei University College of Medicine

    Seoul, 120-752

    Sung-Rae Cho, MD, 82-2-2228-3715, srcho918@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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.

Being tested
Combination injection of EPO and G-CSF, Injection of normal saline
Keywords
Hematopoietic Growth Factors (EPO, G-CSF),, Neurological Diseases,, Neurorehabilitation,, Neurotrophic and Neuroprotective Effects
Medical subject headings
Ischemic Stroke, Hemorrhagic Stroke, Cerebral Palsy, Parkinson Disease, Familial, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination injection of EPO and G-CSFDrug

    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 salineDrug

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

Study groups in NCT02018406
Study groupRoleWhat they receive
InterventionExperimentalIntervention Group
Receives: Drug: Combination injection of EPO and G-CSF
ControlPlacebo comparatorControl Group
Receives: Drug: Injection of normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: at pre-treatment and 6 months after pretest

Secondary outcomes (5)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: at pre-treatment and 6 months after pretest

  5. 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.

    Measured: at pre-treatment and 6 months after pretest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2013 (estimated)
  2. Study start5 Jul 2011
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02018406
Sponsor's protocol ID
4-2010-0468
Status last verified
Dec 2020
First submitted
30 Oct 2013
Last updated
28 Dec 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20610036

  • 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.

    PubMed 17885687

  • 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.

    PubMed 23394350

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Combination injection of EPO and G-CSF and Injection of normal saline in people with Neurological Diseases and Ischemic Stroke, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sung-Rae Cho, MD (82-2-2228-3715, srcho918@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vital Sign (time frame: 5th day, 30th day during a cycle, and 6 months after pretest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018406, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.

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