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Spinal Cord Injury CervicalPhase 1/2NCT05054803

Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

A Phase 1/2 study testing WJ-MSC (XCEL-UMC-BETA) in people with Spinal Cord Injury Cervical, run by Banc de Sang i Teixits at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Cord Injury Cervical
What is being tested?
WJ-MSC (XCEL-UMC-BETA)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
2 sitesSpain
Study dates
13 Oct 2021to 20 Jan 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Complexo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006

  • Hospital de Neurorehabilitació Institut Guttmann

    Badalona, Barcelona, 08916

Other trials in Spain

About this study

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

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.

Read the 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 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.

Being tested
WJ-MSC (XCEL-UMC-BETA), Placebo
Keywords
spinal cord injury, Mesenchymal stromal cells, Wharton jelly, Cell therapy
Medical subject headings
Spinal Cord Injuries

What participants receive

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

  • WJ-MSC (XCEL-UMC-BETA)Drug

    Also called Tested product

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

  • PlaceboDrug

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

Study groups in NCT05054803
Study groupRoleWhat they receive
WJ-MSC (XCEL-UMC-BETA)ExperimentalPre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.
Receives: Drug: WJ-MSC (XCEL-UMC-BETA)
PlaceboPlacebo comparatorPre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin
Receives: Drug: Placebo

What is being measured

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

  1. Incidence of adverse events

    Adverse events

    Measured: At 12 month follow-up

Secondary outcomes (15)

  1. American Spinal Injury Association (ASIA) impairment scale

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

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

  2. Motor evoked potentials

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

    Measured: At 6 and 12 month follow-up

  3. Somatosensory evoked potentials

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

    Measured: At 6 and 12 month follow-up

  4. Electrical pain threshold perception

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

    Measured: At 6 and 12 month follow-up

  5. Handgrip Strength

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

    Measured: At 6 and 12 month follow-up

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

    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)

    Measured: At 6 and 12 month follow-up

  7. Numerical scale for neuropathic pain assessment

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

    Measured: At 6 and 12 month follow-up

  8. Modified Ashworth scale for spasticity

    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.

    Measured: At 6 and 12 month follow-up

  9. Spinal Cord Independence Measure III (SCIM III)

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

    Measured: At 6 and 12 month follow-up

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

    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.

    Measured: At 6 and 12 month follow-up

  11. Psychological general well-being index (PGWBI)

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

    Measured: At 12 month follow-up

  12. Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: At 12 month follow-up

  13. Community Integration Questionaire (CIQ-IG)

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

    Measured: At 12 month follow-up

  14. AntiHLA antibodies in cerebrospinal fluid (CSF)

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

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

  15. Detection of donor cells in CSF

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

    Measured: At 7 days after each infusion

Timeline

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

  1. First posted23 Sep 2021
  2. Study start13 Oct 2021
  3. Primary completion20 Jan 2024
  4. Study completion20 Jan 2024

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
Model description
Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054803
Sponsor's protocol ID
BST-SCI-02
Status last verified
Jan 2024
First submitted
14 Sep 2021
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Albu S, Kumru H, Coll R, Vives J, Valles M, Benito-Penalva J, Rodriguez L, Codinach M, Hernandez J, Navarro X, Vidal J. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021 Feb;23(2):146-156. doi: 10.1016/j.jcyt.2020.08.008. Epub 2020 Sep 25.

    PubMed 32981857

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing WJ-MSC (XCEL-UMC-BETA) in people with Spinal Cord Injury Cervical, run by Banc de Sang i Teixits at 2 sites in Spain.

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 14 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: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: At 12 month follow-up). 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 NCT05054803, which also lists 1 linked publication.

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 24 Jan 2024.

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