This is a prospective, single-blinded, single-center, randomized, comparative, interventional clinical study of systemic mononuclear multiple allogenic cord blood cells administration safety and efficiency in patients having acute severe contusion spinal cord injury (ASIA A/B), phase I/II
Phase I/II of the SUBSCI II (Systemic Umbilical Cord Blood Administration in Patients with Acute Severe Contusion Spinal Cord Injury II) study is focused on safety and primary efficacy of multiple systemic infusions of allogeneic unrelated human umbilical cord blood mononuclear cells in patients with severe acute spinal cord contusion having severe neurologic deficit (ASIA A/B). In a previous clinical study (SUBSCI I/IIa) complete safety and significant efficiency of systemic administration of human umbilical cord blood cells (HUCBCs) was demonstrated. Current study is established to confirm and verify the obtained results in a larger group of patients. SUBSCI II study includes 80 patients with acute severe contusion spinal cord injury (SCI) and American Spinal Injury Association (ASIA) level A/B deficit divided into 2 groups (experimental and control groups, 40 patients in each). Patients will be treated with 4 infusions of group-matched and rhesus-matched cord blood samples following primary decompressive and stabilizing surgery within 7 days after SCI. All patients will be followed up for 12 months after SCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Each HUCBCs sample contain 500 +/- 50 x 10\*6 allogenic non-related group- and rhesus-compatible mononuclear cord blood cells
Sterile saline infusion in control patients
N.V. Sklifosovsky Emergency Care Institute
Moscow, Russia
RECRUITINGAdverse events
All adverse events (AEs) are registered within follow-up period. All registered AEs are classified using CTCAE classification and relation to the performed therapy.
Time frame: Continuously for 12 months post-SCI
Motor function
Evaluation of motor function dynamics in upper (UEMS), lower (LEMS) and all (GEMS) limbs
Time frame: Change from Baseline 12 months post-SCI
Neurological deficit
Evaluation of general neurological deficit dynamics using ASIA scale
Time frame: Change from Baseline 12 months post-SCI
Sensory function
Evaluation of pain, tactile, temperature and proprioceptive sensory function dynamics below SCI level and comparison between two groups
Time frame: Change from Baseline 12 months post-SCI
Neuropathic pain syndrome
Evaluation of neuropathic pain syndrome dynamics and comparison between two groups
Time frame: 12 months post-SCI
Independent verticalization and motion ability
Evaluation of Independent verticalization and motion ability dynamics and comparison between two groups
Time frame: Change from Baseline 12 months post-SCI
Limb muscle spasticity
Evaluation of limb muscle spasticity level dynamics using modified Ashworth or Tardieu scales and comparison between two groups
Time frame: Change from Baseline 12 months post-SCI
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Psychological status
Evaluation of psychological status dynamics using Beck depression and anxiety scales and comparison between two groups
Time frame: Change from Baseline 12 months post-SCI
Pelvic functions
Evaluation of pelvic functions dynamics (bladder fulfillment feeling, independent urination ability, urodynamic examination)
Time frame: Change from Baseline 12 months post-SCI
Life quality
Evaluation of life quality level in two groups using FIM (Functional Independence Measurement) scale and SF36 questionnaire
Time frame: Change from Baseline 12 months post-SCI
Electrophysiology parameters
Assessment of electrophysiology objective parameters (electroneuromyography parameters with transcranial magnetic stimulation - full block, partial block or no block; somatosensory evoked potentials, motor evoked potentials)
Time frame: 12 months post-SCI
Cell immunization
Assessment of patient's immunization to infused cell samples
Time frame: 12 months post-SCI