Atypical Parkinson Disease, Cerebral Palsy, Hemorrhagic Stroke, Ischemic Stroke, Neurological Diseases
Conditions
Keywords
Hematopoietic Growth Factors (EPO, G-CSF),, Neurological Diseases,, Neurorehabilitation,, Neurotrophic and Neuroprotective Effects
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.
Interventions
DRUGCombination 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.
Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Sign | 5th day, 30th day during a cycle, and 6 months after pretest | (1) Value of Systolic and Diastolic Blood Pressure, (2) Value of Pulse Rate, (3) Value of Respiratory Rate, (4) Value of Body Temperature. Vital Sign is tested to confirm the safety of the combination of EPO and G-CSF. |
| Hematological Test | 5th day, 30th day during a cycle, and 6 months after pretest | (1) Value of Complete Blood Cells at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (2) Value of Reticulocyte at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (3) Value of Erythrocyte Sedimentation Rate at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (4) Value of C-Reactive Protein at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (5) Value of Electrolyte and Routine Chemistry at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (6) Value of Prothrombin Time and Activated Partial Thromboplastin Time at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest. Hematological Test is tested to confirm the safety of the combination of EPO and G-CSF. |
| Chest and Heart Evaluation | at pre-treatment and 6 months after pretest | (1) Chest X-ray finding at pre-treatment and 6 months after pretest, (2) Electrocardiography finding at pre-treatment and 6 months after pretest. Chest and Heart Evaluation is tested to confirm the safety of the combination of EPO and G-CSF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Assessment | at pre-treatment and 6 months after pretest | Score of Psychological Status with Mini-Mental Status Examination, Memory Quotient, Geriatric Depression Scale, if necessary Psychological Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF. |
| Hematological Test | 5th day, 30th day during a cycle, and 6 months after pretest | (1) Value of Erythropoietin Level, (2) Value of CD34+ cells. Value of Erythropoietin Level and CD 34+ Cells are tested to demonstrate the hematological changes and effectiveness of the combination of EPO and G-CSF. |
| Verbal Assessment | at pre-treatment and 6 months after pretest | Score of Verbal Function with Aphasia Quotient, Boston Naming Test, Multi-dimensional Voice Performance, if necessary. Verbal Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF. |
| Physical Assessment | at pre-treatment, 3 months, and 6 months after pretest | (1) Score of Muscle Strength with Manual Muscle Testing, (2) Score of Joint Mobility with Range of Motion Test, (3) Score of Muscle Spasticity with Modified Ashworth Scale. Physical Assessment is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF. |
| Occupational Assessment | at pre-treatment, 3 months, and 6 months after pretest | Score of Activities of Daily Living with Modified Barthel Index, Functional Independence Measure. Occupational Assessments is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF. |
Countries
South Korea
Contacts
Primary ContactSung-Rae Cho, MD
Outcome results
None listed