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

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stem cell transplantation
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Cord Blood Stem Cell Transplantation, Pain, Human

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Rehabilitation control group

hUC-MSCs intravenous administration group

hUC-MSCs lumbar administration group

hUC-MSCs local administration group

hUCB-MSCs intravenous administration group

hUCB-MSCs lumbar administration group

hUCB-MSCs local administration group

Arm Description

Routine rehabilitation treatment for chronic spinal cord injury and Intravenous injection of 100 mL 0.9% saline solution.

intravenous administration of 100 mL of cell suspension containing 5×107 hUC-MSCs

lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUC-MSCs and 5 mL of cerebrospinal fluid

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.

intravenous administration of 100 mL of cell suspension containing 5×107 hUCB-MSCs

lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUCB-MSCs and 5 mL of cerebrospinal fluid

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Walking Index of Spinal Cord Injury (WISCI)
To evaluate walking ability
Spinal Cord Independence Measure (SCIM)
To evaluate ability of daily activities after spinal cord injury
Kunming Locomotion Scale (KLS)
To evaluate walking ability
Modified Ashworth Scale (MAS)
0-4 score, to evaluate spasticity
Visual Analogous Scale (VAS)
To evaluate the degree of pain

Full Information

First Posted
December 20, 2019
Last Updated
December 26, 2019
Sponsor
The First Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04213131
Brief Title
Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University

4. Oversight

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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Cord Blood Stem Cell Transplantation, Pain, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation control group
Arm Type
Other
Arm Description
Routine rehabilitation treatment for chronic spinal cord injury and Intravenous injection of 100 mL 0.9% saline solution.
Arm Title
hUC-MSCs intravenous administration group
Arm Type
Experimental
Arm Description
intravenous administration of 100 mL of cell suspension containing 5×107 hUC-MSCs
Arm Title
hUC-MSCs lumbar administration group
Arm Type
Experimental
Arm Description
lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUC-MSCs and 5 mL of cerebrospinal fluid
Arm Title
hUC-MSCs local administration group
Arm Type
Experimental
Arm Description
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.
Arm Title
hUCB-MSCs intravenous administration group
Arm Type
Experimental
Arm Description
intravenous administration of 100 mL of cell suspension containing 5×107 hUCB-MSCs
Arm Title
hUCB-MSCs lumbar administration group
Arm Type
Experimental
Arm Description
lumbar administration of a solution prepared by 5 mL of cell suspension containing 5×107 hUCB-MSCs and 5 mL of cerebrospinal fluid
Arm Title
hUCB-MSCs local administration group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stem cell transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurologic function score
Description
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.
Time Frame
Change from Baseline at 12 months after treatment
Secondary Outcome Measure Information:
Title
Walking Index of Spinal Cord Injury (WISCI)
Description
To evaluate walking ability
Time Frame
Change from Baseline at 12 months after treatment
Title
Spinal Cord Independence Measure (SCIM)
Description
To evaluate ability of daily activities after spinal cord injury
Time Frame
Change from Baseline at 12 months after treatment
Title
Kunming Locomotion Scale (KLS)
Description
To evaluate walking ability
Time Frame
Change from Baseline at 12 months after treatment
Title
Modified Ashworth Scale (MAS)
Description
0-4 score, to evaluate spasticity
Time Frame
Change from Baseline at 12 months after treatment
Title
Visual Analogous Scale (VAS)
Description
To evaluate the degree of pain
Time Frame
Change from Baseline at 12 months after treatment
Other Pre-specified Outcome Measures:
Title
Incidence of adverse reactions
Description
To record adverse reactions after treatment
Time Frame
Before and 1, 3, 6, and 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Liu, Ph.D
Phone
86041184394568
Email
liujing.dlrmc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Liu, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Liu, Ph.D
Phone
86041184394568
Email
liujing.dlrmc@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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