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Completed

NCT Number: NCT01471613

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Kunming, Yunnan, 650032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional treatment

Procedure

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

Lithium Carbonate Tablet

Drug

250mg/tablet, administrated orally for 6 weeks.

Cord Blood Cell

Biological

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

Placebo

Other

Placebo tablet, orally administration of placebo for 6 weeks

Primary outcomes

  1. 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 outcomes

  1. Walking

    Time frame: Week 2, 6, 14, 24, 48

    Walking Index of Spinal Cord Injury (WISCI)

  2. Functional assessment

    Time frame: Week 2, 6, 14, 24, 48

    Spinal Cord Injury Measure (SCIM) Score

  3. Locomotion

    Time frame: Week 2, 6, 14, 24, 48

    Kunming locomotor scales

  4. Spasticity grade

    Time frame: Week 2, 6, 14, 24, 48

    Modified Ashworth Scale

  5. Pain

    Time frame: Week 2, 6, 14, 24, 48

    Numerical rating scales

Sponsors and collaborators

Lead sponsor

China Spinal Cord Injury Network

Network

Collaborators

  • Chengdu PLA General Hospital
  • StemCyte, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 15, 2011
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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