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

China Spinal Cord Injury Network

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Injury

Treatments: Procedure: Conventional Treatment; Other: Placebo; Biological: Cord Blood Cell; Drug: Lithium Carbonate Tablet

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT01471613

CN102c

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups, including a placebo group

Group C - Cord blood cell

Experimental group

Description:

Conventional treatment, cord blood cell transplant and placebo

Treatment:

Other: Placebo

Biological: Cord Blood Cell

Procedure: Conventional Treatment

Group A - Control

Placebo Comparator group

Description:

Conventional treatment and placebo

Treatment:

Other: Placebo

Procedure: Conventional Treatment

Group B - Lithium Carbonate

Experimental group

Description:

Conventional treatment and lithium carbonate

Treatment:

Procedure: Conventional Treatment

Drug: Lithium Carbonate Tablet

Group D - Combination Therapy

Experimental group

Description:

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

Treatment:

Biological: Cord Blood Cell

Procedure: Conventional Treatment

Drug: Lithium Carbonate Tablet