Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
Phase 1
Completed
- Conditions
- Spinal Cord Injury
- Interventions
- Procedure: Conventional TreatmentBiological: Cord Blood CellOther: Placebo
- Registration Number
- NCT01471613
- Lead Sponsor
- China Spinal Cord Injury Network
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C - Cord blood cell Conventional Treatment Conventional treatment, cord blood cell transplant and placebo Group C - Cord blood cell Cord Blood Cell Conventional treatment, cord blood cell transplant and placebo Group C - Cord blood cell Placebo Conventional treatment, cord blood cell transplant and placebo Group A - Control Conventional Treatment Conventional treatment and placebo Group A - Control Placebo Conventional treatment and placebo Group B - Lithium Carbonate Conventional Treatment Conventional treatment and lithium carbonate Group B - Lithium Carbonate Lithium Carbonate Tablet Conventional treatment and lithium carbonate Group D - Combination Therapy Conventional Treatment Conventional treatment, cell transplant and 6-weeks course of lithium carbonate Group D - Combination Therapy Lithium Carbonate Tablet Conventional treatment, cell transplant and 6-weeks course of lithium carbonate Group D - Combination Therapy Cord Blood Cell Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
🇨🇳Kunming, Yunnan, China