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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neurological Diseases Ischemic Stroke Hemorrhagic Stroke Cerebral Palsy Atypical Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Intervention Group

Group Type EXPERIMENTAL

Combination injection of EPO and G-CSF

Intervention Type 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.

Control

Control Group

Group Type PLACEBO_COMPARATOR

Injection of normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Injection of normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No