Clinical trial NCT04528550: Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
Official title: Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2:1 ratio of randomization (intervention group: control group) was used.
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1 month post-treatment
measure: Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
timeFrame: baseline, 3 months, 6 months and 12 months post-treatment
measure: Residual urine test
timeFrame: baseline, 3 months, 6 months and 12 months post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospotal
name: Xuhua Lu
role: PRINCIPAL_INVESTIGATOR
References: