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Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT05054803
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : May 2, 2022
Sponsor:
Collaborators:
Institut Guttmann
Academic Research Organization (ARO) - VHIR
Complexo Hospitalario Universitario A Coruña (CHUAC)
Information provided by (Responsible Party):
Banc de Sang i Teixits

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Cervical Drug: WJ-MSC (XCEL-UMC-BETA) Drug: Placebo Phase 1 Phase 2

Detailed Description:
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 2:1, 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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Active treatment and placebo will be released using the same syringe and blinded in a way that it is no possible to distinguish one to the other.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: WJ-MSC (XCEL-UMC-BETA)
Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.
 Drug: WJ-MSC (XCEL-UMC-BETA)
Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months
Other Name: Tested product
Placebo Comparator: Placebo
Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin
 Drug: Placebo
Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: At 12 month follow-up ]
    Adverse events


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Mechanic ventilation
  2. Penetrating trauma affecting the spinal cord
  3. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
  4. Planned spinal surgery within subsequent 12 month after entering the trial
  5. Neurodegenerative diseases
  6. Significant abnormal laboratory tests that contraindicates patient's participation in the study
  7. Neoplasia within the previous 5 years, or without complete remission
  8. Patient with communication difficulties
  9. 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
  10. Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
  11. Contraindication for lumbar punction
  12. Contraindication or inability to follow a rehabilitation program
  13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054803


Contacts
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Contact: Ruth COLL, MD +34935573500 ext 6707 rucoll@bst.cat
Contact: Joaquin DELGADILLO, MD, PhD +34935573500 ext 6643 jadelgadillo@bst.cat

Locations
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Spain
Hospital de Neurorehabilitació Institut Guttmann Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Joan Vidal, MD, PhD    +34 934977700    jvidal@guttmann.com   
Contact: Jesús Benito, MD, PhD    +34 934977700    jbenito@guttmann.com   
Principal Investigator: Joan Vidal, MD, PhD         
Sub-Investigator: Jesús Benito, MD, PhD         
Sub-Investigator: Hatice Kumru Cam, MD, PhD         
Complexo Hospitalario Universitario A Coruña (CHUAC) Recruiting
A Coruña, Spain, 15006
Contact: Antonio Montoto, MD, PhD    +34 981 178117    antonio.montoto.marques@sergas.es   
Sponsors and Collaborators
Banc de Sang i Teixits
Institut Guttmann
Academic Research Organization (ARO) - VHIR
Complexo Hospitalario Universitario A Coruña (CHUAC)
Investigators
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Principal Investigator: Joan VIDAL, MD, PhD Institut Guttmann
More Information
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Additional Information:

Publications:

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Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT05054803    
Other Study ID Numbers: BST-SCI-02
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Banc de Sang i Teixits:
spinal cord injury
Mesenchymal stromal cells
Wharton jelly
Cell therapy
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System