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

Information source: China Spinal Cord Injury Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury

Intervention: Conventional Treatment (Procedure); Lithium Carbonate Tablet (Drug); Cord Blood Cell (Biological); Placebo (Other)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: China Spinal Cord Injury Network

Official(s) and/or principal investigator(s):
Hui Zhu, MD, Principal Investigator, Affiliation: Chengdu PLA General Hospital

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks

Secondary outcome:

Walking

Functional assessment

Locomotion

Spasticity grade

Pain

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital, Kunming, Yunnan 650032, China
Additional Information

Starting date: September 2011
Last updated: January 27, 2014

Page last updated: August 23, 2015

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