Spinal Cord InjuriesNCT04213131
Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury
A study testing Stem cell transplantation in people with Spinal Cord Injuries, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Jing Liu, Ph.D, 86041184394568, liujing.dlrmc@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Stem cell transplantation
- Keywords
- Spinal Cord Injuries, Cord Blood Stem Cell Transplantation, Pain, Human
- Medical subject headings
- Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell transplantationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation control group | Other | Routine rehabilitation treatment for chronic spinal cord injury and Intravenous injection of 100 mL 0.9% saline solution. Receives: Other: Stem cell transplantation |
| hUC-MSCs intravenous administration group | Experimental | intravenous administration of 100 mL of cell suspension containing 5×107 hUC-MSCs Receives: Other: Stem cell transplantation |
| hUC-MSCs lumbar administration group | Experimental | lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUC-MSCs and 5 mL of cerebrospinal fluid Receives: Other: Stem cell transplantation |
| hUC-MSCs local administration group | Experimental | 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. Receives: Other: Stem cell transplantation |
| hUCB-MSCs intravenous administration group | Experimental | intravenous administration of 100 mL of cell suspension containing 5×107 hUCB-MSCs Receives: Other: Stem cell transplantation |
| hUCB-MSCs lumbar administration group | Experimental | lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUCB-MSCs and 5 mL of cerebrospinal fluid Receives: Other: Stem cell transplantation |
| hUCB-MSCs local administration group | Experimental | 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. Receives: Other: Stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic function score
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.
Measured: Change from Baseline at 12 months after treatment
Secondary outcomes (5)
Walking Index of Spinal Cord Injury (WISCI)
To evaluate walking ability
Measured: Change from Baseline at 12 months after treatment
Spinal Cord Independence Measure (SCIM)
To evaluate ability of daily activities after spinal cord injury
Measured: Change from Baseline at 12 months after treatment
Kunming Locomotion Scale (KLS)
To evaluate walking ability
Measured: Change from Baseline at 12 months after treatment
Modified Ashworth Scale (MAS)
0-4 score, to evaluate spasticity
Measured: Change from Baseline at 12 months after treatment
Visual Analogous Scale (VAS)
To evaluate the degree of pain
Measured: Change from Baseline at 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Jan 2018
- Primary completion30 Oct 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Jing, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Jing Liu, Ph.D, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213131
- Sponsor's protocol ID
- FirstHospitalDalianMU005
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04213131
- Acronym / sponsor ID
- FirstHospitalDalianMU005
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Cord Blood Stem Cell Transplantation, Pain, Human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation control group | Other | Other: Stem cell transplantationRoutine rehabilitation treatment for chronic spinal cord injury and Intravenous injection of 100 mL 0.9% saline solution. |
| hUC-MSCs intravenous administration group | Experimental | Other: Stem cell transplantationintravenous administration of 100 mL of cell suspension containing 5×107 hUC-MSCs |
| hUC-MSCs lumbar administration group | Experimental | Other: Stem cell transplantationlumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUC-MSCs and 5 mL of cerebrospinal fluid |
| hUC-MSCs local administration group | Experimental | Other: Stem cell transplantationhUC-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. |
| hUCB-MSCs intravenous administration group | Experimental | Other: Stem cell transplantationintravenous administration of 100 mL of cell suspension containing 5×107 hUCB-MSCs |
| hUCB-MSCs lumbar administration group | Experimental | Other: Stem cell transplantationlumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUCB-MSCs and 5 mL of cerebrospinal fluid |
| hUCB-MSCs local administration group | Experimental | Other: Stem cell transplantationhUCB-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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cell transplantationThe 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. | Other | Rehabilitation control group, hUC-MSCs intravenous administration group, hUC-MSCs local administration group, hUC-MSCs lumbar administration group, hUCB-MSCs intravenous administration group, hUCB-MSCs local administration group, hUCB-MSCs lumbar administration group |
Primary outcome
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.
5 secondary outcomes
Walking Index of Spinal Cord Injury (WISCI)
Time frame: Change from Baseline at 12 months after treatment
Spinal Cord Independence Measure (SCIM)
Time frame: Change from Baseline at 12 months after treatment
Kunming Locomotion Scale (KLS)
Time frame: Change from Baseline at 12 months after treatment
Modified Ashworth Scale (MAS)
Time frame: Change from Baseline at 12 months after treatment
Visual Analogous Scale (VAS)
Time frame: Change from Baseline at 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Liu, Ph.D principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stem cell transplantation in people with Spinal Cord Injuries, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Liu, Ph.D (86041184394568, liujing.dlrmc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic function score (time frame: Change from Baseline at 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.