Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT04213131 |
Recruitment Status : Unknown
Verified December 2019 by Liu Jing, The First Affiliated Hospital of Dalian Medical University.
Recruitment status was: Recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injuries | Other: Stem cell transplantation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | participants are assigned to one of two or more groups in parallel for the duration of the study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 1, 2018 |
Estimated Primary Completion Date : | October 30, 2020 |
Estimated Study Completion Date : | January 1, 2021 |

Arm | Intervention/treatment |
---|---|
Rehabilitation control group
Routine rehabilitation treatment for chronic spinal cord injury and Intravenous injection of 100 mL 0.9% saline solution.
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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. |
- 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.
- Walking Index of Spinal Cord Injury (WISCI) [ Time Frame: Change from Baseline at 12 months after treatment ]To evaluate walking ability
- 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
- Kunming Locomotion Scale (KLS) [ Time Frame: Change from Baseline at 12 months after treatment ]To evaluate walking ability
- Modified Ashworth Scale (MAS) [ Time Frame: Change from Baseline at 12 months after treatment ]0-4 score, to evaluate spasticity
- Visual Analogous Scale (VAS) [ Time Frame: Change from Baseline at 12 months after treatment ]To evaluate the degree of pain
- Incidence of adverse reactions [ Time Frame: Before and 1, 3, 6, and 12 months after treatment ]To record adverse reactions after treatment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213131
Contact: Jing Liu, Ph.D | 86041184394568 | liujing.dlrmc@hotmail.com |
China, Liaoning | |
The First Affiliated Hospital of Dalian Medical University | Recruiting |
Dalian, Liaoning, China, 116011 | |
Contact: Jing Liu, Ph.D 86041184394568 liujing.dlrmc@hotmail.com |
Principal Investigator: | Jing Liu, Ph.D | The First Affiliated Hospital of Dalian Medical University |
Responsible Party: | Liu Jing, Chief Physician, The First Affiliated Hospital of Dalian Medical University |
ClinicalTrials.gov Identifier: | NCT04213131 |
Other Study ID Numbers: |
FirstHospitalDalianMU005 |
First Posted: | December 30, 2019 Key Record Dates |
Last Update Posted: | December 30, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Spinal Cord Injuries Cord Blood Stem Cell Transplantation Pain Human |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |