Cord Blood Cells in Patients With Acute SCI (NCT05693181) | Clinical Trial Compass
UnknownPhase 1/2
Cord Blood Cells in Patients With Acute SCI
Russia80 participantsStarted 2022-12-05
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ne…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events
Timeframe: Continuously for 12 months post-SCI
2
Motor function
Timeframe: Change from Baseline 12 months post-SCI
3
Neurological deficit
Timeframe: Change from Baseline 12 months post-SCI