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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital

Criteria

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