Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord
Spinal Cord Injuries
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, cord blood mononuclear cell, Methylprednisolone, Lithium Carbonate
Eligibility Criteria
Inclusion Criteria:
- Subjects of either gender and 18-60 years old
- Subjects with chronic spinal cord injury (defined as ≧12 months post-initial SCI surgery) with stable neurological findings for at least 6 months
- Subject with a current neurological status of ASIA A
- The neurological level of the subjects is between C5 and T11
- The MRI shows that the injured site of the spinal cord is within three vertebral levels and there is no cyst
- Subjects must be able to read, understand, and complete the Visual Analog Scale
- Subjects who have voluntarily signed and dated an informed consent form, approved by the appropriate IRB, prior to any study-specific procedures
Exclusion Criteria:
- Significant renal, cardiovascular, hepatic and psychiatric diseases
- Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
- Pregnant or lactating woman
- Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
- The MRI shows that the length of spinal cord lesion exceeds three segments or there is cyst in the spinal cord
- The lesion edge of the spinal cord cannot be determined by imaging technology
- Unavailability of HLA matched umbilical cord blood cells
- Any contraindication of laminectomy operation, MPSS and/or lithium carbonate
- Subject who is currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study and finally
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participant this study
Sites / Locations
- Queen Mary Hospital
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Group A
Group B
Group C
Group D
Group E
Intraspinal injection of 1.6 million cord blood mononuclear cell
Intraspinal injection of 3.2 million cord blood mononuclear cell
Intraspinal injection of 6.4 million cord blood mononuclear cell
Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone
Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone plus 6 week course of oral lithium, titrated to maintain 0.6-1.0 mM serum level