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

July 5, 2021 updated by: Xuhua Lu, Shanghai Changzheng Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200003
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline, 1 month, 3 months, 6 months and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month post-treatment
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
baseline, 3 months, 6 months and 12 months post-treatment
Residual urine test
Time Frame: baseline, 3 months, 6 months and 12 months post-treatment
Change in residual urine as measured by ultrasound test
baseline, 3 months, 6 months and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Investigators

  • Principal Investigator: Xuhua Lu, Shanghai Changzheng Hospotal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202082201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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