Using growth factors to treat brain injuries
Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
PHASE1; PHASE2 · Yonsei University · NCT02018406
This study is testing if a combination of two growth factors can help people with brain injuries, like those from strokes or cerebral palsy, recover better and feel less side effects from current treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02018406 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of combining erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients suffering from neurological diseases such as stroke, cerebral palsy, and atypical parkinsonism. The researchers believe that this combination therapy may enhance the body's natural repair processes and provide neuroprotective benefits. Participants will receive injections of EPO and G-CSF, and their responses will be monitored to establish a clinical basis for this treatment approach. The study seeks to address current limitations in functional recovery and side effects associated with existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with neurological diseases who have had their condition for at least three months.
Not a fit: Patients with certain blood disorders, malignancies, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve recovery outcomes for patients with neurological diseases.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in using growth factors for neurological recovery, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Department of Rehabilitation Medicine, Yonsei University College of Medicine — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Sung-Rae Cho, MD
- Email: srcho918@yuhs.ac
- Phone: 82-2-2228-3715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurological Diseases, Ischemic Stroke, Hemorrhagic Stroke, Cerebral Palsy, Atypical Parkinson Disease, Hematopoietic Growth Factors,, Neurological Diseases,, Neurorehabilitation,