Spinal Cord Injuries Clinical Trial
Official title:
The Effect of Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells in Patients With Early Stage of Chronic Spinal Cord Injury：A Multicenter, Randomized, Controlled Trial
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.
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