NCT02018406

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-05
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2013-12-23
• Last updated: 2020-12-28

Locations

1 site across 1 country: South Korea