Overview

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