Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury

December 26, 2019 updated by: Liu Jing, The First Affiliated Hospital of Dalian Medical University

Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury: a Prospective, Randomized, Open-label, Parallel, and Controlled Clinical Study

There is evidence that human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) can differentiate into oligodendrocytes and neurons, and improve the recovery of nerve function, which strongly suggests the feasibility and effectiveness of hUCB-MSCs as an intervention treatment for spinal cord injury. At present, there are only a few clinical centers in which hUCB-MSCs transplantation for treatment of chronic spinal cord injury has been performed and a certain degree of efficacy has been achieved. However, this has not been supported by systematic standardized randomized controlled trials. Therefore, the investigators design a prospective, randomized, open-label, parallel, controlled trial to evaluate the efficacy of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)/hUCB-MSCs to treat spinal cord injury. The primary objective of this study was to investigate whether hUC-MSCs)/hUCB-MSCs transplantation can improve the locomotor function of patients with spinal cord injury. The secondary objectives were to investigate whether hUC-MSCs)/hUCB-MSCs transplantation can improve the muscle tension of patients with spinal cord injury and investigate the complications and safety of hUC-MSCs)/hUCB-MSCs transplantation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patient recruitment will be performed via information dissemination on bulletin boards to advertise the study among patients at the clinics and wards of the First Affiliated Hospital of Dalian Medical University, China. Patients interested in participation in this study or their legal guardians contact the project manager via telephone. Patients will be screened according to the inclusion and exclusion criteria after providing signed informed consent. Eligible patients with chronic spinal cord injury will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs (provided by Cell Bank of Stem Cell Clinical Research Institute, The First Affiliated Hospital of Dalian Medical University). The primary outcome measure of this study is neurologic function scores, including ASIA (American Spinal Injury Association) motor score, ASIA sensory score, ASIA impairment scale (ASIA classification), and acupuncture score. These scores will be used to evaluate the recovery of nerve function after spinal cord injury and determine the therapeutic efficacy and persistence. The secondary outcome measures of this study include Walking Index of Spinal Cord Injury (WISCI), Spinal Cord Independence Measure (SCIM), Kunming Locomotion Scale (KLS), Modified Ashworth Scale (MAS), and Visual Analogous Scale (VAS) scores and the incidence of adverse reactions. At 1, 3, 6 and 12 months after treatment, patients will be followed up to evaluate the efficacy and safety of hUC-MSCs)/hUCB-MSCs transplantation in the treatment of spinal cord injury.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age at 20-65 years, of either gender;
  • Patients with radiologically confirmed chronic spinal cord injury, with over 1 year of disease history;
  • Patients having no change in ASIA motor score, ASIA sensory score, ASIA impairment scale (ASIA classification) score, and acupuncture score within 6 months and no change in recovery of neurological function;
  • Patients with spinal cord injury who have been relieved of spinal cord compression injury or hematoma clearance;
  • Patients with trauma-caused spinal cord injury accompanied by neurological deficits (sensory, motor, and autonomic dysfunction);
  • Patients who have been subjected to electromyography and urodynamics examination to determine the denervation below the level of spinal cord injury and the function of the detrusor muscle;
  • Patients with normal results of routine blood, urine, and stool tests, blood biochemical parameters, coagulation function, immune indices, electrocardiography and chest radiograph findings, and negative results of human immunodeficiency viruses and syphilis antibody
  • Provision of written informed consent; approval by hospital ethics committee

Exclusion Criteria:

  • Patients with consciousness disorder, lumbosacral infection, or other complications;
  • Patients with spinal cord injury caused by spinal cord compression, syringomyelia, subacute combined degeneration of spinal cord, spinal vascular disease, arachnoiditis of spinal cord, radiation myelopathy, amyotrophic lateral sclerosis, multiple sclerosis, or neuromyelitis optica;
  • Patients with cerebrovascular disease, peripheral neuropathy, history of epilepsy, pregnancy, lactation, diabetes mellitus, mental disorders or other factors that affect the clinical treatment of spinal cord injury;
  • Patients with serious cardiopulmonary disease, liver and kidney function damage, and other serious basic diseases;
  • Patients wearing a metal internal fixator (except titanium alloy) or a pacemaker in the body;
  • Patients with poor compliance who are unable to complete the study process or who are not considered suitable for the study by the investigators;
  • Decline to participate in this study

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Rehabilitation control group
Routine rehabilitation treatment for chronic spinal cord injury and Intravenous injection of 100 mL 0.9% saline solution.
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
EXPERIMENTAL: hUC-MSCs intravenous administration group
intravenous administration of 100 mL of cell suspension containing 5×107 hUC-MSCs
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
EXPERIMENTAL: hUC-MSCs lumbar administration group
lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUC-MSCs and 5 mL of cerebrospinal fluid
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
EXPERIMENTAL: hUC-MSCs local administration group
hUC-MSCs (100,000 cells/μL) were injected via 4 points in the edge of injured spinal cord (2 points in the upper edge and 2 points in the lower edge), 16 μL hUC-MSCs/point.
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
EXPERIMENTAL: hUCB-MSCs intravenous administration group
intravenous administration of 100 mL of cell suspension containing 5×107 hUCB-MSCs
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
EXPERIMENTAL: hUCB-MSCs lumbar administration group
lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUCB-MSCs and 5 mL of cerebrospinal fluid
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
EXPERIMENTAL: hUCB-MSCs local administration group
hUCB-MSCs (100,000 cells/μL) were injected via 4 points in the edge of injured spinal cord (2 points in the upper edge and 2 points in the lower edge), 16 μL hUCB-MSCs/point.
Other: Stem cell transplantation
The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neurologic function score
Time Frame: Change from Baseline at 12 months after treatment
ASIA motor score, ASIA sensory score, ASIA impairment scale (ASIA classification), and acupuncture score will be obtained to evaluate the recovery of nerve function after spinal cord injury and determine the therapeutic efficacy and persistence.
Change from Baseline at 12 months after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking Index of Spinal Cord Injury (WISCI)
Time Frame: Change from Baseline at 12 months after treatment
To evaluate walking ability
Change from Baseline at 12 months after treatment
Spinal Cord Independence Measure (SCIM)
Time Frame: Change from Baseline at 12 months after treatment
To evaluate ability of daily activities after spinal cord injury
Change from Baseline at 12 months after treatment
Kunming Locomotion Scale (KLS)
Time Frame: Change from Baseline at 12 months after treatment
To evaluate walking ability
Change from Baseline at 12 months after treatment
Modified Ashworth Scale (MAS)
Time Frame: Change from Baseline at 12 months after treatment
0-4 score, to evaluate spasticity
Change from Baseline at 12 months after treatment
Visual Analogous Scale (VAS)
Time Frame: Change from Baseline at 12 months after treatment
To evaluate the degree of pain
Change from Baseline at 12 months after treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: Before and 1, 3, 6, and 12 months after treatment
To record adverse reactions after treatment
Before and 1, 3, 6, and 12 months after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Dalian Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FirstHospitalDalianMU005

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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