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

NCT04213131 | Unknown

• 1 other identifier: FirstHospitalDalianMU005
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries; Cord Blood Stem Cell Transplantation; Pain; Human

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at 12 months after treatment

Secondary Outcomes (5)

• Walking Index of Spinal Cord Injury (WISCI)

  Change from Baseline at 12 months after treatment

• Spinal Cord Independence Measure (SCIM)

  Change from Baseline at 12 months after treatment

• Kunming Locomotion Scale (KLS)

  Change from Baseline at 12 months after treatment

• Modified Ashworth Scale (MAS)

  Change from Baseline at 12 months after treatment

• Visual Analogous Scale (VAS)

  Change from Baseline at 12 months after treatment

Other Outcomes (1)

• Incidence of adverse reactions

  Before and 1, 3, 6, and 12 months after treatment

Study Arms (7)

Rehabilitation control group

OTHER

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

Other: Stem cell transplantation

hUC-MSCs intravenous administration group

EXPERIMENTAL

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

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

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.

Other: Stem cell transplantation

hUCB-MSCs intravenous administration group

EXPERIMENTAL

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

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

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.

Other: Stem cell transplantation

Interventions

Stem cell transplantation OTHER

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.

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Pain

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Jing Liu, Ph.D

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liu, Ph.D

CONTACT

86041184394568; liujing.dlrmc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 30, 2019
• Study Start: January 1, 2018
• Primary Completion: October 30, 2020
• Study Completion: January 1, 2021
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

CN (1)