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

December 23, 2020 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Department of Rehabilitation Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention Group
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.
Placebo Comparator: Control
Control Group
Drug: Injection of normal saline
Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital Sign
Time Frame: 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.
5th day, 30th day during a cycle, and 6 months after pretest
Hematological Test
Time Frame: 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.
5th day, 30th day during a cycle, and 6 months after pretest
Chest and Heart Evaluation
Time Frame: 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.
at pre-treatment and 6 months after pretest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological Test
Time Frame: 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.
5th day, 30th day during a cycle, and 6 months after pretest
Physical Assessment
Time Frame: 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.
at pre-treatment, 3 months, and 6 months after pretest
Occupational Assessment
Time Frame: 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.
at pre-treatment, 3 months, and 6 months after pretest
Psychological Assessment
Time Frame: 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.
at pre-treatment and 6 months after pretest
Verbal Assessment
Time Frame: 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.
at pre-treatment and 6 months after pretest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2011

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Actual)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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