Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury (NCT02018406) | Clinical Trial Compass
UnknownPhase 1/2
Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
South Korea60 participantsStarted 2011-07-05
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vital Sign
Timeframe: 5th day, 30th day during a cycle, and 6 months after pretest
2
Hematological Test
Timeframe: 5th day, 30th day during a cycle, and 6 months after pretest
3
Chest and Heart Evaluation
Timeframe: at pre-treatment and 6 months after pretest