A Phase 2 interventional study of Umbilical Cord Mesenchymal Stem Cells and Placebos in Spinal Cord Injuries, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-01.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Phase 2, Interventional, and Treatment
This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment.
In this part of the study, the investigators will treat patients with early stage of chronic spinal cord injury with UC-MSC transplantation or placebo.
Spinal cord injury (SCI), damage to any part of the spinal cord or nerves, often causes permanent neurofunction deficit, including strength, sensation and other body functions below the site of injury. WHO reported 15-40/million people suffer from SCI each year, about 250,000 to 500,000 people. The majority of SCI victims are young patients, who are at the time of working age. As a result of that, SCI not only affects the physical and psychological health of those patients, but also bring huge economic burden to their families, as well as the society. The current treatments for SCI mainly include surgical operation, neuroregenerative medicine, physical therapy, chinese acupuncture and so on. However, none of these methods are efficient enough to make any functional recovery of neurological injury in patients, and most patients will have to face paraplegia or tetraplegia.
The most challenge of SCI treatment are reported to be regeneration of axon and rewiring of the damaged spinal cord. The properties of strong proliferation and differentiation make stem cell transplantation possible to replace the damage axon and rebridge the injury spinal cord. Currently, evidences from animal experiments and pilot clinical studies have reported that umbilical cord mesenchymal stem cells transplantation was a potential method to treat spinal cord injury, but its safety and efficacy remain controversial.
This study will conduct a multicenter, randomized, controlled trial for UC-MSC transplantation for the treatment of different phrases of SCI, including sub-acute, early stage, and late stage of chronic SCI. These three trials will investigate the safety and efficacy of intrathecal transplantation of UC-MSC in patients with SCI treatment. The study will be conducted at 3 hospitals in China, covering eastern, southern and western of Chinese mainland.
The primary outcome is the changes of motor and sensory assessment before and after intervention using American Spinal Injury Association (ASIA) Score Scale. Secondary outcomes will include International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS), electromyogram test, residual urine test and adverse events.
The enrolled participants will be followed up at baseline, 1, 3, 6 and 12 months after UC-MSC transplantation. Besides, the samples of serum and cerebrospinal fluid will be collected, before and after treatment, to explore the potential mechanism of UC-MSC transplantation for the treatment of SCI.
The results of this study will, for the first time, provide high level of evidence as to the relative safety and efficacy of UC-MSC transplantation for the treatment of spinal cord injury.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 66 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1\*10\^6 cells/kg, once a month for 4 months
Drug: Umbilical Cord Mesenchymal Stem Cells
Sham operation and 10ml saline as placebos, once a month for 4 months
Drug: Placebos
Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
Also known as: UC-MSC
Placebos: Saline，Sham operation
Also known as: Sham operation
Changes in American Spinal Injury Association (ASIA) Score Scale
Changes in motor and sensory scores assessed by the ASIA score scale (total score range from 0 to 324, higher values represent a better outcome)
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Changes in International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale (IANR-SCIRFS)
Changes in motor and sensory scores assessed by IANR-SCIRFS scale (total score range from 0 to 51, higher values represent a better outcome)
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months post-treatment
Changes in electromyogram test
Changes in electromyogram test
Time frame: Baseline, 6 months and 12 months post-treatment
Changes in residual urine
Changes in residual urine measured by ultrasound test (volume of urine in mL, lower values represent a better outcome)
Time frame: Baseline, 6 months and 12 months post-treatment
Plan to share: No
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Third Affiliated Hospital, Sun Yat-Sen University