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

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ClinicalTrials.gov Identifier: NCT03003364
Recruitment Status : Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
Hospital de Neurorehabilitació Institut Guttmann
Recerca Clínica S.L.
Syntax for Science
Information provided by (Responsible Party):
Banc de Sang i Teixits

Brief Summary:
This is a phase I/IIa, randomized, double-blind, single-dose, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury, Chronic Drug: XCEL-UMC-BETA Drug: Placebo Phase 1 Phase 2

Detailed Description:
This is a phase I/IIa, randomized, double-blind, single-dose, 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 (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. Results will be initially assessed at 12 month follow-up and thereafter at 24 and 36 months as part of a long-term follow-up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 27, 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: XCEL-UMC-BETA/placebo
Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)
Drug: XCEL-UMC-BETA
Intrathecal allogeneic cell therapy in a blinded syringe
Other Name: Expanded MSC from Wharton Jelly
Drug: Placebo
Placebo in a blinded syringe
Placebo Comparator: Placebo/XCEL-UMC-BETA
Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)
Drug: XCEL-UMC-BETA
Intrathecal allogeneic cell therapy in a blinded syringe
Other Name: Expanded MSC from Wharton Jelly
Drug: Placebo
Placebo in a blinded syringe



Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 12 months ]
    Adverse events


Secondary Outcome Measures :
  1. Extent and severity of a patient's spinal cord injury [ Time Frame: 6 months ]
    ASIA Impairment Scale

  2. Motor electrophysiology assessment [ Time Frame: 6 month ]
    Evoked potentials

  3. Somatosensory electrophysiology assessment [ Time Frame: 6 month ]
    Evoked potentials

  4. Electrical nerve stimulation on pain perception [ Time Frame: 6 month ]
    Pain threshold perception

  5. Mictional dysfunction [ Time Frame: 6 month ]
    Urodynamic testing

  6. Anal sphincter integrity [ Time Frame: 6 month ]
    Anorectal manometry test

  7. Neuropathic pain [ Time Frame: 6 months ]
    Numerical scale (0 to 10)

  8. Spasticity [ Time Frame: 6 months ]
    Modified Ashworth scale

  9. Functionality [ Time Frame: 6 months ]
    SCIM III scale

  10. Quality of life [ Time Frame: 6 months ]
    WHOQOL-BREF

  11. Urinary disorder [ Time Frame: 6 months ]
    Qualiveen questionnaire

  12. Size injury [ Time Frame: 12 months ]
    Magnetic Resonance Imaging

  13. Presence of allogeneic cells [ Time Frame: 1 month ]
    Chimerism in cerebrospinal fluid

  14. Immunology [ Time Frame: 1 months ]
    Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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 T2 and T11, confirmed by magnetic resonance
  3. Complete paraplegia (ASIA A)
  4. Chronic disease state (between 12 months and 5 years after the injury)
  5. Patients from 18 to 65 years of age, both sexes
  6. Life expectancy > 2 years
  7. 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. Lesion affecting multiple levels
  3. Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance
  4. Penetrating trauma affecting the spinal cord
  5. Positive serology to HIV, HBV, HCV and or syphilis
  6. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
  7. Use of metal implants that complicates the MRI interpretation
  8. Planned spinal surgery within subsequent 24 month after entering the trial
  9. Intrathecal medication or immunosuppressive drugs the previous 60 days.
  10. Neurodegenerative diseases
  11. Significant abnormal laboratory tests that contraindicates patient's participation in the study.
  12. Neoplasia within the previous 5 years, or without complete remission
  13. Patient with difficulty for communicating
  14. Participation in another clinical trial or treated with an investigational medicinal product the previous 60 days
  15. Contraindication for lumbar punction
  16. Other pathologic conditions or circumstances that could complicate the participation of the patient in the study according to medical criteria
  17. The patient does not accept to be followed-up for a period that could exceed the clinical trial length

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): NCT03003364


Locations
Spain
Hospital de Neurorehabilitació Institut Guttmann
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Banc de Sang i Teixits
Hospital de Neurorehabilitació Institut Guttmann
Recerca Clínica S.L.
Syntax for Science
Investigators
Principal Investigator: Joan Vidal, MD, PhD Hospital de Neurorehabilitació Institut Guttmann

Additional Information:
Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT03003364     History of Changes
Other Study ID Numbers: XCEL-SCI-01
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System