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NCT Number: NCT05054803

Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.

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Key information

Conditions

Spinal Cord Injury Cervical Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital de Neurorehabilitació Institut Guttmann, Badalona, Barcelona, Spain

Loading trial locations.

About this study

Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single spinal cord injury lesion caused by trauma
  • Affected cord segments between C1 and T1, confirmed by magnetic resonance
  • Incomplete lesion (ASIA B, C or D)
  • Chronic disease state (between 1 and 5 years after the injury)
  • Patients from 18 to 70 years of age, both sexes
  • Life expectancy > 2 years
  • Residence near the center during study participation and confidence that the patient will attend the follow-up visits
  • Given informed consent in writing
  • Patient is able to understand the study and its procedures

Exclusion criteria

  • Mechanic ventilation
  • Penetrating trauma affecting the spinal cord
  • Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
  • Planned spinal surgery within subsequent 12 month after entering the trial
  • Neurodegenerative diseases
  • Significant abnormal laboratory tests that contraindicates patient's participation in the study
  • Neoplasia within the previous 5 years, or without complete remission
  • Patient with communication difficulties
  • Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
  • Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
  • Contraindication for lumbar punction
  • Contraindication or inability to follow a rehabilitation program
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  • The patient does not accept to be followed-up for a period that could exceed the clinical trial length

Treatment and study plan

WJ-MSC (XCEL-UMC-BETA)

Drug

Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months

Other names: Tested product

Placebo

Drug

Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months

Primary outcomes

  1. Incidence of adverse events

    Time frame: At 12 month follow-up

    Adverse events

Secondary outcomes

  1. American Spinal Injury Association (ASIA) impairment scale

    Time frame: At 1, 3, 4, 6 and 12 month follow-up

    Changes in ASIA score with respect to baseline value as detailed at https://asia-spinalinjury.org/international-standards-neurological-classification-sci-isncsci-worksheet/

  2. Motor evoked potentials

    Time frame: At 6 and 12 month follow-up

    Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome

  3. Somatosensory evoked potentials

    Time frame: At 6 and 12 month follow-up

    Changes in somatosensory evoked potentials score with respect to baseline value. Higher scores mean a better outcome

  4. Electrical pain threshold perception

    Time frame: At 6 and 12 month follow-up

    Changes in electrical pain threshold perception score with respect to baseline. Lower scores mean a better outcome

  5. Handgrip Strength

    Time frame: At 6 and 12 month follow-up

    Will be assessed using a dynamometer. Changes in the score with respect to baseline values. Higher scores mean a better outcome

  6. Walking index for spinal cord injury (WISCI II)

    Time frame: At 6 and 12 month follow-up

    Changes in the walk test WISCIII score with respect to baseline value. The score ranges from 0 (most severe impairment) to 20 (least severe impairment)

  7. Numerical scale for neuropathic pain assessment

    Time frame: At 6 and 12 month follow-up

    Changes in the numerical scale for neuropathic pain score with respect to baseline value. Score ranges from 0 (no pain) to 10 (unbearable pain)

  8. Modified Ashworth scale for spasticity

    Time frame: At 6 and 12 month follow-up

    Changes in the modified Ashworth scale score with respect to baseline value. It is a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension, and includes a 1+ value.

  9. Spinal Cord Independence Measure III (SCIM III)

    Time frame: At 6 and 12 month follow-up

    Changes in the SCIM III scale score with respect to baseline value. Score ranges from 0 to 20 with higher scores meaning better outcome.

  10. World Health Organization Quality of life questionnaire (WHOQOL-BREF)

    Time frame: At 6 and 12 month follow-up

    Changes in the WHOQOL-BREF score with respect to baseline value. It contains contains 26 questions each punctuated from 1 to 5 and assesses the individual's overall perception of quality of life (1 to 5), overall perception of their health (1 to 5) and 4 domains of physical health, psychological, social relationships, environment (0-100 each domain). higher scores denote higher quality of life.

  11. Psychological general well-being index (PGWBI)

    Time frame: At 12 month follow-up

    Changes in the PGWBI score with respect to baseline value. Score ranges from 0 to 132, with higher scores meaning a better outcome.

  12. Hospital Anxiety and Depression Scale (HADS)

    Time frame: At 12 month follow-up

    Changes in the HADS score with respect to baseline value. This is a 14-item self-administered questionnaire containing 2 subscales (one for anxiety and one for depression), with a score range of each subscale from 0-21. Higher score indicates higher anxiety and depression.

  13. Community Integration Questionaire (CIQ-IG)

    Time frame: At 12 month follow-up

    Changes in the CIQ-IG score with respect to baseline value. Score ranges from 0 to 25, with higher scores meaning a better outcome.

  14. AntiHLA antibodies in cerebrospinal fluid (CSF)

    Time frame: At 7 days and at 1 month follow-up after each infusion

    Presence or absence of antiHLA antibodies in the CSF after two WJ-MSC infusions

  15. Detection of donor cells in CSF

    Time frame: At 7 days after each infusion

    Short tandem repeat (STR) analysis to detect permanence of donor cellularity (WJ-MsC) in the CSF

Sponsors and collaborators

Lead sponsor

Banc de Sang i Teixits

Other

Collaborators

  • Academic Research Organization (ARO) - VHIR
  • Complexo Hospitalario Universitario de A Coruña
  • Institut Guttmann

Registry information

Official study title

A Phase I/II, Randomized, Double-blind, Placebo-controlled, Parallel, 2-arms Clinical Trial to Assess the Safety and Efficacy of Intrathecal Administration of WJ-MSC in Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2021
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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