NCT01354483

Brief Summary

The purpose of this study is to investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 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

First Submitted

Initial submission to the registry

February 14, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

February 14, 2011

Last Update Submit

August 20, 2014

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuryumbilical cord blood mononuclear celllithium carbonate

Outcome Measures

Primary Outcomes (1)

  • Changes from Baseline in ASIA motor and sensory scores

    Day 0, 3, Week 1, 2, 6, 14, 24, 48

Secondary Outcomes (5)

  • Spinal Cord Independence Measure (SCIM) score

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

  • Walking Index of Spinal Cord Injury (WISCI) Level

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

  • Kunming Walking Score

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

  • Modified Ashworth Scale (MAS)of spasticity

    Day 0, 3, Week 1, 2, 6, 14, 24 48

  • Visual Analog Scale of pain

    Day 0, 3, Week 1, 2, 6, 14, 24, 48

Study Arms (5)

Treatment Group A

EXPERIMENTAL

Umbilical cord blood mononuclear cell, 1.6 million

Biological: Umbilical Cord Blood Mononuclear Cell

Treatment Group B

EXPERIMENTAL

Umbilical cord blood mononuclear cell, 3.2 million

Biological: Umbilical Cord Blood Mononuclear Cell

Treatment Group C

EXPERIMENTAL

Umbilical cord blood mononuclear cell, 6.4 million

Biological: Umbilical Cord Blood Mononuclear Cell

Treatment Group D

EXPERIMENTAL

Umbilical cord blood mononuclear cell, 6.4 million; mehtylprednisolone

Biological: Umbilical Cord Blood Mononuclear CellBiological: Methylprednisolone

Treatment Group E

EXPERIMENTAL

Umbilical cord blood mononuclear cell, 6.4 million; methylprednisolone; 6 week course of lithium carbonate tablet

Biological: Umbilical Cord Blood Mononuclear CellBiological: MethylprednisoloneDrug: Lithium Carbonate Tablet

Interventions

Umbilical Cord Blood Mononuclear CellBIOLOGICAL
Treatment Group ATreatment Group BTreatment Group CTreatment Group DTreatment Group E
MethylprednisoloneBIOLOGICAL

30mg/kg i.v. methylprednisolone

Treatment Group DTreatment Group E
Lithium Carbonate TabletDRUG

6 weeks

Treatment Group E

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with chronic spinal cord injury (\>12 months post-initial spinal cord injury surgery) with stable neurologic findings for at least 6 months
  • Subjects with current neurological status of ASIA A
  • The neurological level of the subjects is between C5 and T11
  • The injured site of the spinal cord is within three vertebral levels
  • Subjects must be able to read, understand, and complete the VAS
  • Subjects who have voluntarily signed and dated an informed consent form prior to any study procedures.

You may not qualify if:

  • Significant renal, cardiovascular, hepatic and psychiatric diseases
  • Significant medical diseases or infection
  • Pregnant or lactating woman
  • Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
  • The length of spinal cord lesion exceeds three segments
  • Unavailability of HLA matched umbilical cord blood cells
  • any contraindication of laminectomy operation, methylprednisolone and/or lithium carbonate
  • Subject who is currently participating in another investigational study or has been taking any investigation drug within the last 4 weeks prior to screening of the study
  • In opinion of the investigator, who suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

MethylprednisoloneLithium Carbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Officials

  • Hui Zhu, MD

    Chengdu PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

May 17, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

CN(1)