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

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Autologous bone marrow-derived mononuclear cells
Placebo
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous bone marrow-derived mononuclear cells

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
Change in sensory and motor function will be measured by SSEP and MED test
Residual urine test
Change in residual urine as measured by ultrasound test

Full Information

First Posted
August 24, 2020
Last Updated
July 5, 2021
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04528550
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A 2:1 ratio of randomization (intervention group: control group) was used.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous bone marrow-derived mononuclear cells
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Included patients will receive the same amount of saline through lumbar injection.
Intervention Type
Biological
Intervention Name(s)
Autologous bone marrow-derived mononuclear cells
Intervention Description
Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Included patients will receive the same amount of saline through lumbar injection.
Primary Outcome Measure Information:
Title
American Spinal Injury Association (ASIA) Impairment Scale
Description
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).
Time Frame
baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
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
Time Frame
1 month post-treatment
Title
Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test
Description
Change in sensory and motor function will be measured by SSEP and MED test
Time Frame
baseline, 3 months, 6 months and 12 months post-treatment
Title
Residual urine test
Description
Change in residual urine as measured by ultrasound test
Time Frame
baseline, 3 months, 6 months and 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuhua Lu, M.D.
Phone
86-21-81885793
Email
xuhualu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bangke Zhang, M.D.
Phone
8618301783716
Email
zbk12345@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuhua Lu
Organizational Affiliation
Shanghai Changzheng Hospotal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoguang Li, M.D.
Phone
86-21-81885045
Email
Chzhhospital@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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