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Spinal Cord Injury, AcutePhase 1/2SUBSCI IINCT05693181

Cord Blood Cells in Patients With Acute SCI

A Phase 1/2 study testing Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells in people with Spinal Cord Injury, Acute, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Spinal Cord Injury, Acute
What is being tested?
Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteRussia
Study dates
5 Dec 2022to 30 Aug 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site, 1 recruiting

  • N.V. Sklifosovsky Emergency Care Institute

    Moscow, 129090

    Vladimir A. Smirnov, M.D., Ph.D., +7-925-750-39-22, vla_smirnov@mail.ru

    Sergey E. Zuev, M.D., +7-915-377-00-80, zu85@bk.ru

    Recruiting

Other trials in Russia

About this study

Official title: 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 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

Read the 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.

Being tested
Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells, Control vehicle (sterile saline)
Keywords
spinal cord injury, SCI, neurological deficit, stem cells, cell therapy, regenerative, paraplegia, tetraplegia
Medical subject headings
Spinal Cord Injuries, Neurologic Manifestations, Paraplegia, Quadriplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Control vehicle (sterile saline)Other

    Sterile saline infusion in control patients

Study groups in NCT05693181
Study groupRoleWhat they receive
Cell TherapyExperimentalPatients 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.
Receives: Biological: Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells
VehiclePlacebo comparatorPatients 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.
Receives: Other: Control vehicle (sterile saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Continuously for 12 months post-SCI

  2. Motor function

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

    Measured: Change from Baseline 12 months post-SCI

  3. Neurological deficit

    Evaluation of general neurological deficit dynamics using ASIA scale

    Measured: Change from Baseline 12 months post-SCI

Secondary outcomes (9)

  1. Sensory function

    Evaluation of pain, tactile, temperature and proprioceptive sensory function dynamics below SCI level and comparison between two groups

    Measured: Change from Baseline 12 months post-SCI

  2. Neuropathic pain syndrome

    Evaluation of neuropathic pain syndrome dynamics and comparison between two groups

    Measured: 12 months post-SCI

  3. Independent verticalization and motion ability

    Evaluation of Independent verticalization and motion ability dynamics and comparison between two groups

    Measured: Change from Baseline 12 months post-SCI

  4. Limb muscle spasticity

    Evaluation of limb muscle spasticity level dynamics using modified Ashworth or Tardieu scales and comparison between two groups

    Measured: Change from Baseline 12 months post-SCI

  5. Psychological status

    Evaluation of psychological status dynamics using Beck depression and anxiety scales and comparison between two groups

    Measured: Change from Baseline 12 months post-SCI

  6. Pelvic functions

    Evaluation of pelvic functions dynamics (bladder fulfillment feeling, independent urination ability, urodynamic examination)

    Measured: Change from Baseline 12 months post-SCI

  7. Life quality

    Evaluation of life quality level in two groups using FIM (Functional Independence Measurement) scale and SF36 questionnaire

    Measured: Change from Baseline 12 months post-SCI

  8. Electrophysiology parameters

    Assessment of electrophysiology objective parameters (electroneuromyography parameters with transcranial magnetic stimulation - full block, partial block or no block; somatosensory evoked potentials, motor evoked potentials)

    Measured: 12 months post-SCI

  9. Cell immunization

    Assessment of patient's immunization to infused cell samples

    Measured: 12 months post-SCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start5 Dec 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05693181
Sponsor's protocol ID
007-2022
Acronym
SUBSCI II
Status last verified
Jan 2023
First submitted
21 Nov 2022
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Personal contacts via E-mail or phone after the completion of the study

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Multiple systemic (i.v.) administration of allogenic non-related group- and rhesus-compatible mononuclear cord blood cells in people with Spinal Cord Injury, Acute, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Continuously for 12 months post-SCI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05693181.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.

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