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

No results posted yet for this study

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

Lithium

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01046786 on ClinicalTrials.gov