Cord Blood Cells in Patients With Acute SCI (SUBSCI II)
Spinal Cord Injury, Acute
About this trial
This is an interventional treatment trial for Spinal Cord Injury, Acute focused on measuring spinal cord injury, SCI, neurological deficit, stem cells, cell therapy, regenerative, paraplegia, tetraplegia
Eligibility Criteria
Inclusion Criteria: Both males and females, 18 to 75 years old Contusion spinal cord injury (SCI) at cervical, thoracic or upper lumbar (cone level) levels admission by 7 days post-SCI spinal cord contusion confirmed using MRI (T1- and T2-weighted images, STIR) ASIA A/B neurological deficit identical level of neurological deficit at admission and at the moment of patient inclusion primary decompressive and stabilizing surgery performed within 5 days post-SCI and prior to the first cell sample infused patient is ready to participate and fulfill the requirements of the study protocol informed consent signed by the patient or his legal representative Exclusion Criteria: motor function preserved in lower limbs at admission (LEMS > 0 points) corresponding to ASIA C, D or E deficit level any spinal cord injury different from contusion (tear, defibering, concussion, SCIWORA, SCIWONA) confirmed using MRI severe 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 infused persistent 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 inclusion acute myocardial infarction blood glucose level < 3.5 Mmol/L or >21 Mmol/L or ineffective antidiabetic therapy for 24 hours acute 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 inclusion objective need for artificial ling ventilation (ALV) at admission or prior to the stage I surgery acute 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 functions acute of deterioration of chronic diseases of internal organs preventing from cell samples infusion autoimmune diseases (active or anamnestic) preventing from cell samples infusion allergic reactions of any type for any component of HUCBC samples pregnancy or lactation significant surgeries or severe traumas within 3 months prior to patient inclusion acute 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 infusion any malignant tumors (both operated and not operated) or benign tumors (not operated or not totally removed) at the moment of patient inclusion neurological and/or psychiatric diseases preventing patient from complete understanding of study protocol or fulfillment of the study protocol requirements other reasons preventing patient from complete understanding of study protocol or fulfillment of the study protocol requirements patient's participation in any other clinical trials or studies within 6 months prior to inclusion immunosuppressive therapy obtained by the patient for any reason at admission allergic reaction for full blood or blood component transfusion in the past need for extracorporal detoxication methods application (hemodialysis, plasmapheresis, sorption etc.) bone marrow or internal organs (both donor and relative) transplantation in the past patient's participation in any studies applying regenerative technologies (grow factors, cytokines, cell therapy, gene therapy etc.) within 1 year prior to inclusion patient's rejection to sign the informed consent any other reasons preventing patient's inclusion according to the investigator's opinion
Sites / Locations
- N.V. Sklifosovsky Emergency Care InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cell Therapy
Vehicle
Patients having acute severe contusion spinal cord injury (cervical, thoracic or upper-lumbar) and ASIA A/B neurological deficit, within 7 days post-SCI, after primary decompressive and stabilizing surgery. All participants meet inclusion and exclusion criteria. All participants obtain 4 infusions of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells samples (500 +/- 50 x 10*6 cells each) with a 1-week interval. All participants are followed up for 12 months post-SCI.
Patients having acute severe contusion spinal cord injury (cervical, thoracic or upper-lumbar) and ASIA A/B neurological deficit, within 7 days post-SCI, after primary decompressive and stabilizing surgery. All participants meet inclusion and exclusion criteria. All participants obtain 4 infusions of vehicle (sterile saline) with a 1-week interval. All participants are followed up for 12 months post-SCI.