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

Spinal Cord Injury Clinical Trial

Official title:

Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528550
• Other study ID #: 202082201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2021
• Source: Shanghai Changzheng Hospital
• Contact: Xuhua Lu, M.D.
• Phone: 86-21-81885793
• Email: xuhualu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• Autologous bone marrow-derived mononuclear cells
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.

Drug:
• Placebo
Included patients will receive the same amount of saline through lumbar injection.

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary	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	1 month post-treatment
Secondary	Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test	Change in sensory and motor function will be measured by SSEP and MED test	baseline, 3 months, 6 months and 12 months post-treatment
Secondary	Residual urine test	Change in residual urine as measured by ultrasound test	baseline, 3 months, 6 months and 12 months post-treatment