Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury

Shanghai Changzheng Hospital45 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged between 18 and 60 years * Traumatic spinal cord injury * ASIA Impairment Scale A-D * The injury must be within two weeks * Patients submitted written informed consent Exclusion Criteria: * Traumatic spinal cord injury with brain injury or peripheral nerve injury * Patients with severe multiple injuries and unstable vital signs * Non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc. * Patients with central spinal cord injury * Patients with a completely transected spinal cord * Patients with fever or acute infection * Ongoing infectious disease, such as tuberculosis, HIV, hepatitis, syphilis, etc. * Patients with anemia, coagulopathy, and other known blood system diseases * Patients with malignant tumour * Patients with neurodegenerative diseases, or any neuropathies * Patients with ankylosing spondylitis * Patients with a previous history of spinal surgery * Patients who are pregnant or possibly pregnant * Patients with psychiatric, addictive or any other mental disorders that can not give a truly informed consent * Patients who are participating in other clinical trials

Outcomes

Primary Outcomes

American Spinal Injury Association (ASIA) Impairment Scale

Change in sensory and motor function as measured by the American Spinal Injury Association (ASIA) Impairment Scale. The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal).

Time frame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment

Secondary Outcomes

Incidence of adverse events

Any abnormal signs, symptoms, findings, or diseases that emerge or worsen relative to baseline in 1 month post-treatment will be recorded as adverse event

Time frame: 1 month post-treatment

Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test

Change in sensory and motor function will be measured by SSEP and MED test

Time frame: baseline, 3 months, 6 months and 12 months post-treatment

Residual urine test

Change in residual urine as measured by ultrasound test

Time frame: baseline, 3 months, 6 months and 12 months post-treatment

Central Contacts

Xuhua Lu, M.D.

CONTACT

86-21-81885793 xuhualu@hotmail.com

Bangke Zhang, M.D.