Trial | NCT01471613  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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 Started
Sep 30
2011
Primary Completion
Dec 31
2013
Study Completion
Jan 31
2014
Last Update
Jan 28
2014
Estimate

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

Group C - Cord blood cell Experimental

Conventional treatment, cord blood cell transplant and placebo

Group A - Control Placebo Comparator

Conventional treatment and placebo

Group B - Lithium Carbonate Experimental

Conventional treatment and lithium carbonate

Group D - Combination Therapy Experimental

Conventional treatment, cell transplant and 6-weeks course of lithium carbonate

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
No Results Posted