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Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Primary Purpose

Spinal Cord Injury Cervical

Status
Active
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
WJ-MSC (XCEL-UMC-BETA)
Placebo
Sponsored by
Banc de Sang i Teixits
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury Cervical focused on measuring spinal cord injury, Mesenchymal stromal cells, Wharton jelly, Cell therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Neurorehabilitació Institut Guttmann
  • Complexo Hospitalario Universitario A Coruña (CHUAC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

WJ-MSC (XCEL-UMC-BETA)

Placebo

Arm Description

Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.

Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin

Outcomes

Primary Outcome Measures

Incidence of adverse events
Adverse events

Secondary Outcome Measures

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/
Motor evoked potentials
Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome
Somatosensory evoked potentials
Changes in somatosensory evoked potentials score with respect to baseline value. Higher scores mean a better outcome
Electrical pain threshold perception
Changes in electrical pain threshold perception score with respect to baseline. Lower scores mean a better outcome
Handgrip Strength
Will be assessed using a dynamometer. Changes in the score with respect to baseline values. Higher scores mean a better outcome
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)
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)
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.
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.
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.
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.
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.
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.
AntiHLA antibodies in cerebrospinal fluid (CSF)
Presence or absence of antiHLA antibodies in the CSF after two WJ-MSC infusions
Detection of donor cells in CSF
Short tandem repeat (STR) analysis to detect permanence of donor cellularity (WJ-MsC) in the CSF

Full Information

First Posted
September 14, 2021
Last Updated
July 14, 2023
Sponsor
Banc de Sang i Teixits
Collaborators
Institut Guttmann, Academic Research Organization (ARO) - VHIR, Complexo Hospitalario Universitario de A Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT05054803
Brief Title
Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Institut Guttmann, Academic Research Organization (ARO) - VHIR, Complexo Hospitalario Universitario de A Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical
Keywords
spinal cord injury, Mesenchymal stromal cells, Wharton jelly, Cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, placebo-controlled, 2-arms, multicenter clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WJ-MSC (XCEL-UMC-BETA)
Arm Type
Experimental
Arm Description
Pre-filled syringe with 4 ± 1 mL containing WJ-MSC in a balanced saline solution supplemented with human albumin.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pre-filled syringe with 4 ± 1 mL containing a balanced saline solution supplemented with human albumin
Intervention Type
Drug
Intervention Name(s)
WJ-MSC (XCEL-UMC-BETA)
Other Intervention Name(s)
Tested product
Intervention Description
Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Adverse events
Time Frame
At 12 month follow-up
Secondary Outcome Measure Information:
Title
American Spinal Injury Association (ASIA) impairment scale
Description
Changes in ASIA score with respect to baseline value as detailed at https://asia-spinalinjury.org/international-standards-neurological-classification-sci-isncsci-worksheet/
Time Frame
At 1, 3, 4, 6 and 12 month follow-up
Title
Motor evoked potentials
Description
Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome
Time Frame
At 6 and 12 month follow-up
Title
Somatosensory evoked potentials
Description
Changes in somatosensory evoked potentials score with respect to baseline value. Higher scores mean a better outcome
Time Frame
At 6 and 12 month follow-up
Title
Electrical pain threshold perception
Description
Changes in electrical pain threshold perception score with respect to baseline. Lower scores mean a better outcome
Time Frame
At 6 and 12 month follow-up
Title
Handgrip Strength
Description
Will be assessed using a dynamometer. Changes in the score with respect to baseline values. Higher scores mean a better outcome
Time Frame
At 6 and 12 month follow-up
Title
Walking index for spinal cord injury (WISCI II)
Description
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)
Time Frame
At 6 and 12 month follow-up
Title
Numerical scale for neuropathic pain assessment
Description
Changes in the numerical scale for neuropathic pain score with respect to baseline value. Score ranges from 0 (no pain) to 10 (unbearable pain)
Time Frame
At 6 and 12 month follow-up
Title
Modified Ashworth scale for spasticity
Description
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.
Time Frame
At 6 and 12 month follow-up
Title
Spinal Cord Independence Measure III (SCIM III)
Description
Changes in the SCIM III scale score with respect to baseline value. Score ranges from 0 to 20 with higher scores meaning better outcome.
Time Frame
At 6 and 12 month follow-up
Title
World Health Organization Quality of life questionnaire (WHOQOL-BREF)
Description
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.
Time Frame
At 6 and 12 month follow-up
Title
Psychological general well-being index (PGWBI)
Description
Changes in the PGWBI score with respect to baseline value. Score ranges from 0 to 132, with higher scores meaning a better outcome.
Time Frame
At 12 month follow-up
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
At 12 month follow-up
Title
Community Integration Questionaire (CIQ-IG)
Description
Changes in the CIQ-IG score with respect to baseline value. Score ranges from 0 to 25, with higher scores meaning a better outcome.
Time Frame
At 12 month follow-up
Title
AntiHLA antibodies in cerebrospinal fluid (CSF)
Description
Presence or absence of antiHLA antibodies in the CSF after two WJ-MSC infusions
Time Frame
At 7 days and at 1 month follow-up after each infusion
Title
Detection of donor cells in CSF
Description
Short tandem repeat (STR) analysis to detect permanence of donor cellularity (WJ-MsC) in the CSF
Time Frame
At 7 days after each infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan VIDAL, MD, PhD
Organizational Affiliation
Institut Guttmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Neurorehabilitació Institut Guttmann
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña (CHUAC)
City
A Coruña
ZIP/Postal Code
15006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32981857
Citation
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.
Results Reference
background
Links:
URL
https://www.bancsang.net
Description
Blood and tissue bank of Catalonia, cell producer and sponsor of the trial
URL
https://www.guttmann.com/
Description
Hospital specialized in spinal cord injury
URL
https://xxicoruna.sergas.gal/Paxinas/web.aspx?tipo=paxtxt&idContido=595&idLista=4
Description
Hospital specialized in spinal cord injury

Learn more about this trial

Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

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