Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Spinal Cord Injury Network
• Collaborators: Chinese University of Hong Kong; The University of Hong Kong
• Treatments: Lithium Carbonate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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