Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord
NCT01046786 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2014-01-28
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.
Conditions
- Spinal Cord Injuries
Interventions
- BIOLOGICAL
-
Umbilical Cord Blood Mononuclear Cell
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
- DRUG
-
Methylprednisolone
30 mg/kg methylprednisolone
- DRUG
-
oral lithium, titrated to maintain 0.6-1.0 mM serum level
Sponsors & Collaborators
-
Chinese University of Hong Kong
collaborator OTHER -
The University of Hong Kong
collaborator OTHER -
China Spinal Cord Injury Network
lead NETWORK
Principal Investigators
-
Wai Sang Poon, MD · The Chinese University of Hong Kong / Prince of Wales Hospital
-
Gilberto Leung, MD · The University of Hong Kong / Queen Mary Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2013-10-31
- Completion
- 2013-12-31
Countries
- Hong Kong
Study Locations
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