Cord Blood Cells in Patients With Acute SCI

NCT ID: NCT05693181

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2025-08-30

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

Detailed Description

Phase I/II of the SUBSCI II (Systemic Umbilical Cord Blood Administration in Patients with Acute Severe Contusion Spinal Cord Injury II) study is focused on safety and primary efficacy of multiple systemic infusions of allogeneic unrelated human umbilical cord blood mononuclear cells in patients with severe acute spinal cord contusion having severe neurologic deficit (ASIA A/B).

In a previous clinical study (SUBSCI I/IIa) complete safety and significant efficiency of systemic administration of human umbilical cord blood cells (HUCBCs) was demonstrated. Current study is established to confirm and verify the obtained results in a larger group of patients.

SUBSCI II study includes 80 patients with acute severe contusion spinal cord injury (SCI) and American Spinal Injury Association (ASIA) level A/B deficit divided into 2 groups (experimental and control groups, 40 patients in each). Patients will be treated with 4 infusions of group-matched and rhesus-matched cord blood samples following primary decompressive and stabilizing surgery within 7 days after SCI. All patients will be followed up for 12 months after SCI.

Conditions

Spinal Cord Injury, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cell Therapy

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

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 vehicle (sterile saline) with a 1-week interval. All participants are followed up for 12 months post-SCI.

Group Type: PLACEBO_COMPARATOR

Control vehicle (sterile saline)

Intervention Type: OTHER

Sterile saline infusion in control patients

Interventions

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

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

Intervention Type: BIOLOGICAL

Control vehicle (sterile saline)

Sterile saline infusion in control patients

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State-Financed Health Facility "Samara Regional Medical Center Dinasty"

OTHER

Sponsor Role: collaborator

K.L. Hetagurov North-Osetian State University

UNKNOWN

Sponsor Role: collaborator

Sklifosovsky Institute of Emergency Care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vladimir A. Smirnov

Senior researcher, M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

N.V. Sklifosovsky Emergency Care Institute

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Facility Contacts

Vladimir A. Smirnov, M.D., Ph.D.

Role: primary

vla_smirnov@mail.ru

+7-925-750-39-22

Sergey E. Zuev, M.D.

Role: backup

zu85@bk.ru

+7-915-377-00-80

Other Identifiers

007-2022

Identifier Type: -

Identifier Source: org_study_id