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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471613
First Posted: November 15, 2011
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Chengdu PLA General Hospital
StemCyte, Inc.
Information provided by (Responsible Party):
China Spinal Cord Injury Network
  Purpose
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

Condition Intervention Phase
Spinal Cord Injury Procedure: Conventional Treatment Drug: Lithium Carbonate Tablet Biological: Cord Blood Cell Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by China Spinal Cord Injury Network:

Primary Outcome Measures:
  • 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 Measures:
  • Walking [ Time Frame: Week 2, 6, 14, 24, 48 ]
    Walking Index of Spinal Cord Injury (WISCI)

  • Functional assessment [ Time Frame: Week 2, 6, 14, 24, 48 ]
    Spinal Cord Injury Measure (SCIM) Score

  • Locomotion [ Time Frame: Week 2, 6, 14, 24, 48 ]
    Kunming locomotor scales

  • Spasticity grade [ Time Frame: Week 2, 6, 14, 24, 48 ]
    Modified Ashworth Scale

  • Pain [ Time Frame: Week 2, 6, 14, 24, 48 ]
    Numerical rating scales


Enrollment: 16
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group C - Cord blood cell
Conventional treatment, cord blood cell transplant and placebo
Procedure: Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
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
Placebo Comparator: Group A - Control
Conventional treatment and placebo
Procedure: Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Other: Placebo
Placebo tablet, orally administration of placebo for 6 weeks
Experimental: Group B - Lithium Carbonate
Conventional treatment and lithium carbonate
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.
Experimental: Group D - Combination Therapy
Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471613


Locations
China, Yunnan
Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
Kunming, Yunnan, China, 650032
Sponsors and Collaborators
China Spinal Cord Injury Network
Chengdu PLA General Hospital
StemCyte, Inc.
Investigators
Principal Investigator: Hui Zhu, MD Chengdu PLA General Hospital
  More Information

Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01471613     History of Changes
Other Study ID Numbers: CN102c
First Submitted: October 12, 2011
First Posted: November 15, 2011
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by China Spinal Cord Injury Network:
spinal cord injury
umbilical cord blood cell
cell transplant
lithium carbonate

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs


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