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

Yonsei University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ischemic Stroke; Atypical Parkinson Disease; Neurological Diseases; Cerebral Palsy; Hemorrhagic Stroke

Treatments: Drug: Combination injection of EPO and G-CSF; Drug: Injection of normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02018406

4-2010-0468

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Intervention Group

Treatment:

Drug: Combination injection of EPO and G-CSF

Control

Placebo Comparator group

Description:

Control Group

Treatment:

Drug: Injection of normal saline