Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury

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

Summary

The purpose of this study is 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
• Collaborator: Chengdu PLA General Hospital
• Treatments: Lithium Carbonate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Subjects with chronic spinal cord injury (>12 months post-initial spinal cord injury surgery) with stable neurologic findings for at least 6 months

• Subjects with current neurological status of ASIA A

• The neurological level of the subjects is between C5 and T11

• The injured site of the spinal cord is within three vertebral levels

• Subjects must be able to read, understand, and complete the VAS

• Subjects who have voluntarily signed and dated an informed consent form prior to any study procedures.

Exclusion Criteria:

• Significant renal, cardiovascular, hepatic and psychiatric diseases

• Significant medical diseases or infection

• Pregnant or lactating woman

• Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study

• The length of spinal cord lesion exceeds three segments

• Unavailability of HLA matched umbilical cord blood cells

• any contraindication of laminectomy operation, methylprednisolone and/or lithium carbonate

• Subject who is currently participating in another investigational study or has been taking any investigation drug within the last 4 weeks prior to screening of the study

• In opinion of the investigator, who suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate the study