AzTrials
AzTrials

Spinal Cord Injury, ChronicPhase 1/2NCT03003364

Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury

A Phase 1/2 study testing XCEL-UMC-BETA in people with Spinal Cord Injury, Chronic, run by Banc de Sang i Teixits at 1 site in Spain.

Completed

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

Official record
Search all trials

Trial summary

This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury, Chronic
What is being tested?
XCEL-UMC-BETA
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteSpain
Study dates
27 Dec 2016to 11 Feb 2020
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 65 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 T2 and T11, confirmed by magnetic resonance
  • Complete paraplegia (ASIA A)
  • Chronic disease state (between 12 months and 5 years after the injury)
  • Patients from 18 to 65 years of age, both sexes
  • Life expectancy > 2 years
Show all 9Show fewer
  • 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
  • Lesion affecting multiple levels
  • Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance
  • Penetrating trauma affecting the spinal cord
  • Positive serology to HIV, HBV, HCV and or syphilis
  • Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
Show all 17Show fewer
  • Use of metal implants that complicates the MRI interpretation
  • Planned spinal surgery within subsequent 24 month after entering the trial
  • Intrathecal medication or immunosuppressive drugs the previous 60 days.
  • 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 difficulty for communicating
  • Participation in another clinical trial or treated with an investigational medicinal product the previous 60 days
  • Contraindication for lumbar punction
  • Other pathologic conditions or circumstances that could complicate the participation of the patient 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

1 site in 1 country.

Spain1 site

  • Hospital de Neurorehabilitació Institut Guttmann

    Badalona, Barcelona, 08916

Other trials in Spain

About this study

Official title: A Phase I/IIa, Randomized, Double-blind, Single-dose, Placebo Controlled, Two-way Crossover Clinical Trial to Assess the Safety and to Obtain Efficacy Data in Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury

This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.

Read the detailed description

This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration (L3 level) of expanded Wharton's jelly mesenchymal stem cells. Following the administration patients will remain for 24 h at the hospital and thereafter will be discharged. For the first period, the follow-up is planned at day 7 and at 1, 3 and 6 months. At month 6, the patients will be treated in a crossover way (second period) and will follow the same schedule for the follow-up. First clinical trial evaluation will be performed at 12 month follow-up. From 12 to 18 month after the first infusion, patients will be randomized again to active treatment or placebo (double-blind) in order to assess the safety and efficacy of a second dose at 12 month follow-up. Thereafter, patients will be followed up at 24 and 36 months as part of a long-term follow-up.

Being tested
XCEL-UMC-BETA, Placebo
Medical subject headings
Spinal Cord Injuries, Bronchiolitis Obliterans Syndrome

What participants receive

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

  • XCEL-UMC-BETADrug

    Also called Expanded MSC from Wharton Jelly

    Intrathecal allogeneic cell therapy in a blinded syringe

  • PlaceboDrug

    Placebo in a blinded syringe

Study groups in NCT03003364
Study groupRoleWhat they receive
XCEL-UMC-BETA/placeboExperimentalEx vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)
Receives: Drug: XCEL-UMC-BETA; Drug: Placebo
Placebo/XCEL-UMC-BETAPlacebo comparatorPlacebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)
Receives: Drug: XCEL-UMC-BETA; Drug: Placebo

What is being measured

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

  1. Incidence of treatment-emergent adverse events

    Adverse events

    Measured: 12 months

Secondary outcomes (14)

  1. Extent and severity of a patient's spinal cord injury

    ASIA Impairment Scale

    Measured: 6 months

  2. Motor electrophysiology assessment

    Evoked potentials

    Measured: 6 month

  3. Somatosensory electrophysiology assessment

    Evoked potentials

    Measured: 6 month

  4. Electrical nerve stimulation on pain perception

    Pain threshold perception

    Measured: 6 month

  5. Mictional dysfunction

    Urodynamic testing

    Measured: 6 month

  6. Anal sphincter integrity

    Anorectal manometry test

    Measured: 6 month

  7. Neuropathic pain

    Numerical scale (0 to 10)

    Measured: 6 months

  8. Spasticity

    Modified Ashworth scale

    Measured: 6 months

  9. Functionality

    SCIM III scale

    Measured: 6 months

  10. Quality of life (individual overall perception of quality of life, individual overall perception of their health, Physical health, Psychological, Social relationships, Environment)

    WHOQOL BREF questionnaire

    Measured: 6 months

  11. Urinary disorder

    Qualiveen questionnaire

    Measured: 6 months

  12. Size injury

    Magnetic Resonance Imaging

    Measured: 12 months

  13. Presence of allogeneic cells

    Chimerism in cerebrospinal fluid

    Measured: 1 month

  14. Immunology

    Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid

    Measured: 1 months

Timeline

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

  1. First posted28 Dec 2016 (estimated)
  2. Study start27 Dec 2016
  3. Primary completion25 Jul 2019
  4. Study completion11 Feb 2020

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003364
Sponsor's protocol ID
XCEL-SCI-01
Status last verified
Feb 2020
First submitted
14 Dec 2016
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
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 XCEL-UMC-BETA in people with Spinal Cord Injury, Chronic, run by Banc de Sang i Teixits at 1 site 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 17 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 17 Feb 2020. 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 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 treatment-emergent adverse events (time frame: 12 months). 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 NCT03003364, 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 17 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in