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

Naval Military Medical University (Second Military Medical University)

Status and phase: Enrolling; Phase 2

Conditions: Spinal Cord Injury

Treatments: Drug: Placebo; Biological: Autologous bone marrow-derived mononuclear cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04528550

202082201

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups, including a placebo group

Autologous bone marrow-derived mononuclear cells

Experimental group

Description:

Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection in acute phase. Each included patient will receive a single dose of 100 million autologous bone marrow-derived mononuclear cells.

Treatment:

Biological: Autologous bone marrow-derived mononuclear cells

Control

Placebo Comparator group

Description:

Included patients will receive the same amount of saline through lumbar injection.

Treatment:

Drug: Placebo