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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
  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
Biological: Cord Blood Cell
Other: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group C - Cell
Conventional treatment, 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
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
Lithium carbonate, 250mg/tablet, administrated orally for 6 weeks. The serum lithium level is achieved and maintained at 0.6-1.0 mM
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01471613     History of Changes
Other Study ID Numbers: CN102c
Study First Received: October 12, 2011
Last Updated: May 12, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Lithium
 Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013