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

NCT02018406 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-12-28

No results posted yet for this study

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

Interventions

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.

DRUG

Injection of normal saline

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-05
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02018406 on ClinicalTrials.gov