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Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury

NCT01471613 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-01-28

No results posted yet for this study

Summary

The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury

Conditions

  • Spinal Cord Injury

Interventions

PROCEDURE

Conventional Treatment

Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury

DRUG

Lithium Carbonate Tablet

250mg/tablet, administrated orally for 6 weeks.

BIOLOGICAL

Cord Blood Cell

Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site

OTHER

Placebo

Placebo tablet, orally administration of placebo for 6 weeks

Sponsors & Collaborators

  • Chengdu PLA General Hospital

    collaborator OTHER

  • StemCyte, Inc.

    collaborator INDUSTRY

  • China Spinal Cord Injury Network

    lead NETWORK

Principal Investigators

  • Hui Zhu, MD · Chengdu PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • China

Study Locations

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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 NCT01471613 on ClinicalTrials.gov