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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471613

Enrollment

Registered

2011-11-15

Start date

2011-09-30

Completion date

2014-01-31

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury, umbilical cord blood cell, cell transplant, lithium carbonate

Brief 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

Interventions

PROCEDUREConventional Treatment

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

DRUGLithium Carbonate Tablet

250mg/tablet, administrated orally for 6 weeks.

BIOLOGICALCord 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

OTHERPlacebo

Placebo tablet, orally administration of placebo for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026