Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of repeated intrathecal
      administrations of allogeneic human umbilical cord mesenchymal stem cells for the treatment
      of spinal cord injury.
    

Detailed description: 
      Spinal cord injury (SCI) is a devastating disease and often leads to lifelong disability,
      muscle spasm, sensory deficits, autonomic disturbances, as well as bowel and bladder
      incontinence, all of which can cause tremendous troubles to patients but are lack of any
      effective treatment up to now. SCI is not only a severe healthy problem but also a great
      social burden. To the best of our knowledge, cell therapy seems to be a promising alternative
      for the treatment of SCI due to numerous advantages. However, cytotherapy is still in its
      infancy since there are many disparities and uncertainties regarding subject selection,
      cellular type, transplantation timing, administration dose and deliver route in clinical
      trial protocols. Hence, a standardized well-designed clinical study is urgently required for
      the safe and effective treatment of SCI.

      In this study, complete or incomplete cervical, thoracic, and thoracolumbar SCI subjects were
      recruited to join in a prospective, single-center, single-arm clinical trial. Intervention is
      four times of subarachnoid administration of allogeneic hUC-MSCs. During the intervention and
      follow-up periods of this trial, any adverse event was identified rapidly and managed
      properly. The maximum intensity and relationship of any adverse event with hUC-MSCs
      administration were identified.The primary efficacy indicator is American spinal injury
      association (ASIA) total score at the fourth follow-up and SCI Functional Rating Scale of the
      International Association of Neurorestoratology (IANR-SCIFRS) total score at the fourth
      follow-up. Secondary efficacy indicators are these two indicators at the remaining time
      points, scores of pin prick, light touch, motor and sphincter, muscle spasticity and spasm,
      autonomic system, bladder and bowel functions, residual urine volume. Subgroup analysis of
      primary efficacy indicators was also performed.

      In this trial, informed consent forms that had the approval of the institutional review board
      were obtained from all participants before recruitment. In this clinical study, subarachnoid
      transplantation of hUC-MSCs was performed a total of four times per subject with the delivery
      dose of 1×10E6 cells/kg. After the completion of cytotherapy, subject was regularly followed
      up in the hospital at four time points, determined at 1, 3, 6, and 12 months following the
      final administration of hUC-MSCs. At each time point of administration (the first, second,
      third, and fourth transplantation) and follow-up (the first, second, third, and fourth
      follow-up), safety and efficacy indicators were collected accordingly by two independent
      assessors.
    

Intervention name(s): human umbilical cord mesenchymal stem cells (hUC-MSCs)
Intervention type(s): Biological
Intervention description(s): Four times of intrathecal administrations of hUC-MSCs
Other intervention name(s): umbilical cord mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: human umbilical cord mesenchymal stem cells; spinal cord injury