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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528550
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Xuhua Lu, Shanghai Changzheng Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Autologous bone marrow-derived mononuclear cells Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 2:1 ratio of randomization (intervention group: control group) was used.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous bone marrow-derived mononuclear cells
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.
 Biological: Autologous bone marrow-derived mononuclear cells
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
Placebo Comparator: Control
Included patients will receive the same amount of saline through lumbar injection.
 Drug: Placebo
Included patients will receive the same amount of saline through lumbar injection.


Outcome Measures
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Primary Outcome Measures :
  1. American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: baseline, 1 month, 3 months, 6 months and 12 months post-treatment ]
    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).


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 1 month post-treatment ]
    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

  2. Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test [ Time Frame: baseline, 3 months, 6 months and 12 months post-treatment ]
    Change in sensory and motor function will be measured by SSEP and MED test

  3. Residual urine test [ Time Frame: baseline, 3 months, 6 months and 12 months post-treatment ]
    Change in residual urine as measured by ultrasound test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528550


Contacts
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Contact: Xuhua Lu, M.D. 86-21-81885793 xuhualu@hotmail.com
Contact: Bangke Zhang, M.D. 8618301783716 zbk12345@163.com

Locations
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China
Shanghai Changzheng Hospital Recruiting
Shanghai, China, 200003
Contact: Xiaoguang Li, M.D.    86-21-81885045    Chzhhospital@163.com   
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
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Principal Investigator: Xuhua Lu Shanghai Changzheng Hospotal
More Information
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Responsible Party: Xuhua Lu, Director of Traumatic Orthopaedic Department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT04528550    
Other Study ID Numbers: 202082201
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System