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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471613
• Other study ID #: CN102c
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 12, 2011
• Last updated: January 27, 2014
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Other:
• Placebo
Placebo tablet, orally administration of placebo for 6 weeks

Locations

Country	Name	City	State
China	Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital	Kunming	Yunnan

Sponsors (3)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	Chengdu PLA General Hospital, StemCyte, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Walking	Walking Index of Spinal Cord Injury (WISCI)	Week 2, 6, 14, 24, 48	No
Secondary	Functional assessment	Spinal Cord Injury Measure (SCIM) Score	Week 2, 6, 14, 24, 48	No
Secondary	Locomotion	Kunming locomotor scales	Week 2, 6, 14, 24, 48	No
Secondary	Spasticity grade	Modified Ashworth Scale	Week 2, 6, 14, 24, 48	No
Secondary	Pain	Numerical rating scales	Week 2, 6, 14, 24, 48	No