Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury

Launched by DA NANG HOSPITAL · Oct 3, 2016

Keywords

ClinConnect Summary

Recruitment process:

The investigators selects the candidate of the study that fulfill the inclusion criteria and not violate any exclusion criteria from patients with spinal cord injury that admitted to the department of neurosurgery - Danang hospital. The investigators then ask the patients and patients family for informed consent. The patients that submit the informed consent to participate is recruited to the study.

Procedure description:

The patients is moved to operation theater at the day of the procedure. The bone marrow of the patients is harvested by two investigators. The mono...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with spinal cord injuries classified as A-B on the ASIA impairment scale
• • 2. Patients injured 3 weeks to 1 year previously
• • 3. Patients with partial spinal cord injury demonstrated by diagnostic imaging
• • 4. Patients aged between 20 and 60 years at the acquisition of informed consent
• • 5. Patients who submitted written informed consent by themselves
• Exclusion Criteria:
• • 1. Patients with a completely transected spinal cord
• • 2. Patients with central spinal cord injury
• • 3. Patients with organ failure with SOFA score of 3 points or higher
• • 4. Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, or leukemia infection cannot be denied
• • 5. Patients with malignant tumour or a history of malignant tumour within 5 years
• 6. Patients with following disease/disorder:
• • Myeloproliferative disorder or myelodysplastic syndrome Poorly controlled ischemic heart disease Autoimmune disease Spinal stenosis Limb paralysis due to central nervous system disorder not attributed to spinal cord injury Hepatic dysfunction Renal dysfunction Poorly controlled psychiatric disorder Complex multiple trauma
• • 7. Patients who are participating in other clinical trials or who completed participation within 6 months
• • 8. Patients who are pregnant or possibly pregnant
• • 9. Other patients who are judged to be ineligible by investigators