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

Sponsor
Shanghai Changzheng Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04528550
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
38
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: Autologous bone marrow-derived mononuclear cells
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A 2:1 ratio of randomization (intervention group: control group) was used.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 :
Oct 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. American Spinal Injury Association (ASIA) Impairment Scale [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 [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 [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 [baseline, 3 months, 6 months and 12 months post-treatment]

    Change in residual urine as measured by ultrasound test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Shanghai Changzheng Hospital Shanghai China 200003

Sponsors and Collaborators

  • Shanghai Changzheng Hospital

Investigators

  • Principal Investigator: Xuhua Lu, Shanghai Changzheng Hospotal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xuhua Lu, Director of Traumatic Orthopaedic Department, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT04528550
Other Study ID Numbers:
  • 202082201
First Posted:
Aug 27, 2020
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries

Study Results

No Results Posted as of Jul 7, 2021