Clinical trial NCT01471613: Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
umbilical cord blood cell
cell transplant
lithium carbonate
Lead sponsor: China Spinal Cord Injury Network
Sponsor class: NETWORK
Collaborators: name: Chengdu PLA General Hospital
name: StemCyte, Inc.
First posted: 2011-11-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks
timeFrame: Week 0, 1, 2, 6, 14, 24 and 48
Secondary outcomes:
measure: Walking
timeFrame: Week 2, 6, 14, 24, 48
measure: Functional assessment
timeFrame: Week 2, 6, 14, 24, 48
measure: Locomotion
timeFrame: Week 2, 6, 14, 24, 48
measure: Spasticity grade
timeFrame: Week 2, 6, 14, 24, 48
measure: Pain
timeFrame: Week 2, 6, 14, 24, 48
Other outcomes:
Locations:
city: Kunming
country: China
facility: Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
state: Yunnan
Study officials:
affiliation: Chengdu PLA General Hospital
name: Hui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: