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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2025
  • participants needed
    60
  • sponsor
    Yonsei University
Updated on 26 January 2021

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.

Details
Condition Cerebral Palsy, Cerebral Palsy (Pediatric), Cerebral Palsy, INTRACRANIAL HEMORRHAGE, Cerebral Palsy (Pediatric), Ischemic Stroke, Neurological Diseases, Atypical Parkinson Disease, hemorrhagic stroke, hemorrhage brain, cerebral palsy (cp)
Treatment Injection of Normal Saline, Combination injection of EPO and G-CSF
Clinical Study IdentifierNCT02018406
SponsorYonsei University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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 38C
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
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