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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Conventional Treatment
Lithium Carbonate Tablet
Cord Blood Cell
Placebo
Sponsored by
China Spinal Cord Injury Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, umbilical cord blood cell, cell transplant, lithium carbonate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Group C - Cord blood cell

Group A - Control

Group B - Lithium Carbonate

Group D - Combination Therapy

Arm Description

Conventional treatment, cord blood cell transplant and placebo

Conventional treatment and placebo

Conventional treatment and lithium carbonate

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Walking
Walking Index of Spinal Cord Injury (WISCI)
Functional assessment
Spinal Cord Injury Measure (SCIM) Score
Locomotion
Kunming locomotor scales
Spasticity grade
Modified Ashworth Scale
Pain
Numerical rating scales

Full Information

First Posted
October 12, 2011
Last Updated
January 27, 2014
Sponsor
China Spinal Cord Injury Network
Collaborators
Chengdu PLA General Hospital, StemCyte, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01471613
Brief Title
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
Official Title
Safety and Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Spinal Cord Injury Network
Collaborators
Chengdu PLA General Hospital, StemCyte, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, umbilical cord blood cell, cell transplant, lithium carbonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C - Cord blood cell
Arm Type
Experimental
Arm Description
Conventional treatment, cord blood cell transplant and placebo
Arm Title
Group A - Control
Arm Type
Placebo Comparator
Arm Description
Conventional treatment and placebo
Arm Title
Group B - Lithium Carbonate
Arm Type
Experimental
Arm Description
Conventional treatment and lithium carbonate
Arm Title
Group D - Combination Therapy
Arm Type
Experimental
Arm Description
Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
Intervention Type
Procedure
Intervention Name(s)
Conventional Treatment
Intervention Description
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate Tablet
Intervention Description
250mg/tablet, administrated orally for 6 weeks.
Intervention Type
Biological
Intervention Name(s)
Cord Blood Cell
Intervention Description
Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet, orally administration of placebo for 6 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
Time Frame
Week 0, 1, 2, 6, 14, 24 and 48
Secondary Outcome Measure Information:
Title
Walking
Description
Walking Index of Spinal Cord Injury (WISCI)
Time Frame
Week 2, 6, 14, 24, 48
Title
Functional assessment
Description
Spinal Cord Injury Measure (SCIM) Score
Time Frame
Week 2, 6, 14, 24, 48
Title
Locomotion
Description
Kunming locomotor scales
Time Frame
Week 2, 6, 14, 24, 48
Title
Spasticity grade
Description
Modified Ashworth Scale
Time Frame
Week 2, 6, 14, 24, 48
Title
Pain
Description
Numerical rating scales
Time Frame
Week 2, 6, 14, 24, 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhu, MD
Organizational Affiliation
Chengdu PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China

12. IPD Sharing Statement

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

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