Efficacy and Safety of hUC-MSCs and hUCB-MSCs in the Treatment of Chronic Spinal Cord Injury
Unknown statusNot applicableNCT04213131
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Interventions
- Other: Stem cell transplantation
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Start date
- 2018-01-01
- Primary completion
- 2020-10-30
- Sex
- All
- Age range
- from 20 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04213131