Clinical trial NCT02018406: Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neurological Diseases
Ischemic Stroke
Hemorrhagic Stroke
Cerebral Palsy
Atypical Parkinson Disease
Keywords: Hematopoietic Growth Factors (EPO, G-CSF),
Neurological Diseases,
Neurorehabilitation,
Neurotrophic and Neuroprotective Effects
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vital Sign
timeFrame: 5th day, 30th day during a cycle, and 6 months after pretest
measure: Hematological Test
timeFrame: 5th day, 30th day during a cycle, and 6 months after pretest
measure: Chest and Heart Evaluation
timeFrame: at pre-treatment and 6 months after pretest
Secondary outcomes:
measure: Hematological Test
timeFrame: 5th day, 30th day during a cycle, and 6 months after pretest
measure: Physical Assessment
timeFrame: at pre-treatment, 3 months, and 6 months after pretest
measure: Occupational Assessment
timeFrame: at pre-treatment, 3 months, and 6 months after pretest
measure: Psychological Assessment
timeFrame: at pre-treatment and 6 months after pretest
measure: Verbal Assessment
timeFrame: at pre-treatment and 6 months after pretest
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Im SH, Yu JH, Park ES, Lee JE, Kim HO, Park KI, Kim GW, Park CI, Cho SR. Induction of striatal neurogenesis enhances functional recovery in an adult animal model of neonatal hypoxic-ischemic brain injury. Neuroscience. 2010 Aug 11;169(1):259-68. doi: 10.1016/j.neuroscience.2010.04.038.
citation: Cho SR, Benraiss A, Chmielnicki E, Samdani A, Economides A, Goldman SA. Induction of neostriatal neurogenesis slows disease progression in a transgenic murine model of Huntington disease. J Clin Invest. 2007 Oct;117(10):2889-902. doi: 10.1172/JCI31778.
citation: Seo JH, Kim H, Park ES, Lee JE, Kim DW, Kim HO, Im SH, Yu JH, Kim JY, Lee MY, Kim CH, Cho SR. Environmental enrichment synergistically improves functional recovery by transplanted adipose stem cells in chronic hypoxic-ischemic brain injury. Cell Transplant. 2013;22(9):1553-68. doi: 10.3727/096368912X662390. Epub 2013 Feb 4.