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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Chengdu PLA General Hospital
StemCyte, Inc.
Information provided by (Responsible Party):
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT01471613
First received: October 12, 2011
Last updated: May 12, 2013
Last verified: May 2013
History of Changes

October 12, 2011
May 12, 2013
September 2011
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01471613 on ClinicalTrials.gov Archive Site
  • Walking [ Time Frame: Week 2, 6, 14, 24, 48 ] [ Designated as safety issue: No ]
    Walking Index of Spinal Cord Injury (WISCI)
  • Functional assessment [ Time Frame: Week 2, 6, 14, 24, 48 ] [ Designated as safety issue: No ]
    Spinal Cord Injury Measure (SCIM) Score
  • Locomotion [ Time Frame: Week 2, 6, 14, 24, 48 ] [ Designated as safety issue: No ]
    Kunming locomotor scales
  • Spasticity grade [ Time Frame: Week 2, 6, 14, 24, 48 ] [ Designated as safety issue: No ]
    Modified Ashworth Scale
  • Pain [ Time Frame: Week 2, 6, 14, 24, 48 ] [ Designated as safety issue: No ]
    Numerical rating scales
Same as current
Not Provided
Not Provided
 
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
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

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
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injury
  • 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
    Lithium carbonate, 250mg/tablet, administrated orally for 6 weeks. The serum lithium level is achieved and maintained at 0.6-1.0 mM
  • 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
  • Experimental: Group C - Cell
    Conventional treatment, cell transplant and placebo
    Interventions:
    • Procedure: Conventional Treatment
    • Biological: Cord Blood Cell
    • Other: Placebo
  • Placebo Comparator: Group A - Control
    Conventional treatment and placebo
    Interventions:
    • Procedure: Conventional Treatment
    • Other: Placebo
  • Experimental: Group B - Lithium
    Conventional treatment and lithium carbonate
    Interventions:
    • Procedure: Conventional Treatment
    • Drug: Lithium Carbonate
  • Experimental: Group D - Combination Therapy
    Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
    Interventions:
    • Procedure: Conventional Treatment
    • Drug: Lithium Carbonate
    • Biological: Cord Blood Cell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
October 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01471613
CN102c
Not Provided
China Spinal Cord Injury Network
China Spinal Cord Injury Network
  • Chengdu PLA General Hospital
  • StemCyte, Inc.
Principal Investigator: Hui Zhu, MD Chengdu PLA General Hospital
China Spinal Cord Injury Network
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP