Cord Blood Cells in Patients With Acute SCI

NCT05693181 | Unknown Phase 1 DMC

• 1 other identifier: 007-2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Spinal Cord Injury, Acute

Keywords

spinal cord injury; SCI; neurological deficit; stem cells; cell therapy; regenerative; paraplegia; tetraplegia

Outcome Measures

Primary Outcomes (3)

• Adverse events

  All adverse events (AEs) are registered within follow-up period. All registered AEs are classified using CTCAE classification and relation to the performed therapy.

  Continuously for 12 months post-SCI

• Motor function

  Evaluation of motor function dynamics in upper (UEMS), lower (LEMS) and all (GEMS) limbs

  Change from Baseline 12 months post-SCI

• Neurological deficit

  Evaluation of general neurological deficit dynamics using ASIA scale

  Change from Baseline 12 months post-SCI

Secondary Outcomes (9)

• Sensory function

  Change from Baseline 12 months post-SCI

• Neuropathic pain syndrome

  12 months post-SCI

• Independent verticalization and motion ability

  Change from Baseline 12 months post-SCI

• Limb muscle spasticity

  Change from Baseline 12 months post-SCI

• Psychological status

  Change from Baseline 12 months post-SCI

Study Arms (2)

Cell Therapy

EXPERIMENTAL

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.

Biological: Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells

Vehicle

PLACEBO COMPARATOR

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.

Other: Control vehicle (sterile saline)

Interventions

Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells BIOLOGICAL

Each HUCBCs sample contain 500 +/- 50 x 10\*6 allogenic non-related group- and rhesus-compatible mononuclear cord blood cells

Cell Therapy

Control vehicle (sterile saline) OTHER

Sterile saline infusion in control patients

Vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead
• State-Financed Health Facility "Samara Regional Medical Center Dinasty": collaborator
• K.L. Hetagurov North-Osetian State University: collaborator

Study Sites (1)

N.V. Sklifosovsky Emergency Care Institute

Moscow, 129090, Russia

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neurologic Manifestations; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the experimental group will obtain 4 systemic (i.v.) infusions of allogenic group- and rhesus-compatible non-related mononuclear cord blood cell samples (500 +/- 50 x 10'6 cells each). Participants in the control group will obtain the similar volume of vehicle (sterile saline). Participant's devision will be performed in a randomized manner. Randomization will be performed using standard randomization computer table. All participants will be blinded concerning the therapy mode.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, M.D., Ph.D.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: January 20, 2023
• Study Start: December 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: August 30, 2025
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

RU (1)