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 range18 Years – 75 Years
SexALL
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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…
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