Cord Blood Cells in Patients With Acute SCI

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

Inclusion Criteria:Both males and females, 18 to 75 years oldContusion spinal cord injury (SCI) at cervical, thoracic or upper lumbar (cone level) levelsadmission by 7 days post-SCIspinal cord contusion confirmed using MRI (T1- and T2-weighted images, STIR)ASIA A/B neurological deficitidentical level of neurological deficit at admission and at the moment of patient inclusionprimary decompressive and stabilizing surgery performed within 5 days post-SCI and prior to the first cell sample infusedpatient is ready to participate and fulfill the requirements of the study protocolinformed consent signed by the patient or his legal representativeExclusion Criteria:motor function preserved in lower limbs at admission (LEMS > 0 points) corresponding to ASIA C, D or E deficit levelany spinal cord injury different from contusion (tear, defibering, concussion, SCIWORA, SCIWONA) confirmed using MRIsevere combined trauma (ISS > 35 points)inability to perform primary decompressive and stabilizing surgery within 5 days post-SCI and prior to the first cell sample infusedpersistent systolic arterial pressure (AP) > 185 mmHg or diastolic AP > 105 mmHg or need of aggressive AP lowering using systemic antihypertensive medication at the moment of patient inclusionacute myocardial infarctionblood glucose level < 3.5 Mmol/L or >21 Mmol/L or ineffective antidiabetic therapy for 24 hoursacute or deterioration of chronic diseases of central nervous system (CNS) (e.g. stroke, non-traumatic subarachnoid hemorrhages and others at the discretion of investigator)hypotension or cardiovascular shock AND systolic AP < 90 mmHg OR need for intensive systemic inotropic therapy at the moment of patient inclusionobjective need for artificial ling ventilation (ALV) at admission or prior to the stage I surgeryacute kidney failure or deterioration of chronic kidney failure (creatinin level > 250 mumol/L or carbamide level > 25 Mmol/L)liver failure (general bilirubin level > 25 mumol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels > 4 times exceeding upper reference limit)other significant disorders of vital functionsacute of deterioration of chronic diseases of internal organs preventing from cell samples infusionautoimmune diseases (active or anamnestic) preventing from cell samples infusionallergic reactions of any type for any component of HUCBC samplespregnancy or lactationsignificant surgeries or severe traumas within 3 months prior to patient inclusionacute or chronic infection diseases (tuberculosis, lues, HIV, hepatitis B, hepatitis C etc.)moderate or severe hematological and/or oncohematological diseases preventing from the cell samples infusionany malignant tumors (both operated and not operated) or benign tumors (not operated or not totally removed) at the moment of patient inclusionneurological and/or psychiatric diseases preventing patient from complete understanding of study protocol or fulfillment of the study protocol requirementsother reasons preventing patient from complete understanding of study protocol or fulfillment of the study protocol requirementspatient's participation in any other clinical trials or studies within 6 months prior to inclusionimmunosuppressive therapy obtained by the patient for any reason at admissionallergic reaction for full blood or blood component transfusion in the pastneed for extracorporal detoxication methods application (hemodialysis, plasmapheresis, sorption etc.)bone marrow or internal organs (both donor and relative) transplantation in the pastpatient's participation in any studies applying regenerative technologies (grow factors, cytokines, cell therapy, gene therapy etc.) within 1 year prior to inclusionpatient's rejection to sign the informed consentany other reasons preventing patient's inclusion according to the investigator's opinion