Using cord blood cells to treat acute spinal cord injuries
Systemic Administration of Allogenic Mononuclear Cord Blood Cells in Patients With Acute Severe Contusion Spinal Cord Injury: Safety and Efficiency Evaluation, Stages I/II
This study is testing if using cord blood cells can help people with severe spinal cord injuries recover better than those who receive a saline solution.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sklifosovsky Institute of Emergency Care Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05693181 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of administering allogeneic human umbilical cord blood mononuclear cells to patients with acute severe spinal cord injuries. It involves a randomized, single-blinded approach with two groups: one receiving the cord blood cells and the other receiving a control saline solution. The study aims to confirm previous findings regarding the benefits of cord blood cell therapy in improving neurological outcomes. Patients will be monitored for 12 months following treatment to assess the long-term effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with acute severe contusion spinal cord injuries and ASIA A/B neurological deficits.
Not a fit: Patients with preserved motor function in the lower limbs or other types of spinal cord injuries may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with acute spinal cord injuries.
How similar studies have performed: Previous studies have shown safety and significant efficacy of similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow
- N.V. Sklifosovsky Emergency Care Institute — Moscow, Russian Federation (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.