NCT01471613

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

October 12, 2011

Last Update Submit

January 27, 2014

Conditions

Spinal Cord Injury

Keywords

spinal cord injuryumbilical cord blood cellcell transplantlithium carbonate

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks

    Week 0, 1, 2, 6, 14, 24 and 48

Secondary Outcomes (5)

  • Walking

    Week 2, 6, 14, 24, 48

  • Functional assessment

    Week 2, 6, 14, 24, 48

  • Locomotion

    Week 2, 6, 14, 24, 48

  • Spasticity grade

    Week 2, 6, 14, 24, 48

  • Pain

    Week 2, 6, 14, 24, 48

Study Arms (4)

Group C - Cord blood cell

EXPERIMENTAL

Conventional treatment, cord blood cell transplant and placebo

Procedure: Conventional TreatmentBiological: Cord Blood CellOther: Placebo

Group A - Control

PLACEBO COMPARATOR

Conventional treatment and placebo

Procedure: Conventional TreatmentOther: Placebo

Group B - Lithium Carbonate

EXPERIMENTAL

Conventional treatment and lithium carbonate

Procedure: Conventional TreatmentDrug: Lithium Carbonate Tablet

Group D - Combination Therapy

EXPERIMENTAL

Conventional treatment, cell transplant and 6-weeks course of lithium carbonate

Procedure: Conventional TreatmentDrug: Lithium Carbonate TabletBiological: Cord Blood Cell

Interventions

Conventional TreatmentPROCEDURE

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

Group A - ControlGroup B - Lithium CarbonateGroup C - Cord blood cellGroup D - Combination Therapy
Lithium Carbonate TabletDRUG

250mg/tablet, administrated orally for 6 weeks.

Group B - Lithium CarbonateGroup D - Combination Therapy
Cord Blood CellBIOLOGICAL

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

Group C - Cord blood cellGroup D - Combination Therapy
PlaceboOTHER

Placebo tablet, orally administration of placebo for 6 weeks

Group A - ControlGroup C - Cord blood cell

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • either gender and 18-65 years old;
  • acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks);
  • neurological status of ASIA A;
  • neurological level between C5-T11;
  • MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter;
  • professional judgment determinate that subjects need a spinal decompression surgery;
  • subjects able to complete neurological examination;
  • subjects have voluntarily signed and dated an informed consent form.

You may not qualify if:

  • penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions;
  • spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord;
  • severe complications;
  • significant medical diseases or infection;
  • pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study;
  • unavailability of suitable umbilical cord blood cells;
  • contraindication of lithium carbonate and/or spinal decompression surgery
  • subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening;
  • investigator suggests that the subject would not be suitable to participate this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Lithium CarbonateCord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium CompoundsStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hui Zhu, MD

    Chengdu PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

November 15, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

CN(1)