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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Procedure: Conventional Treatment; Biological: Cord Blood Cell; Other: Placebo; Drug: Lithium Carbonate Tablet

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; Drug: Lithium Carbonate Tablet; 250mg/tablet, administrated orally for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks	Week 0, 1, 2, 6, 14, 24 and 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking	Walking Index of Spinal Cord Injury (WISCI)	Week 2, 6, 14, 24, 48
Functional assessment	Spinal Cord Injury Measure (SCIM) Score	Week 2, 6, 14, 24, 48
Locomotion	Kunming locomotor scales	Week 2, 6, 14, 24, 48
Spasticity grade	Modified Ashworth Scale	Week 2, 6, 14, 24, 48
Pain	Numerical rating scales	Week 2, 6, 14, 24, 48

Collaborators and Investigators

• Sponsor: China Spinal Cord Injury Network
• Collaborators: Chengdu PLA General Hospital; StemCyte, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (ESTIMATE): November 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: spinal cord injury; lithium carbonate; umbilical cord blood cell; cell transplant
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: CN102c