Back to resultsIntrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury
Primary Purpose
Spinal Cord Injury, Chronic
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
XCEL-UMC-BETA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury, Chronic
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
- 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
- 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
Sites / Locations
- Hospital de Neurorehabilitació Institut Guttmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XCEL-UMC-BETA/placebo
Placebo/XCEL-UMC-BETA
Arm Description
Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)
Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events
Adverse events
Secondary Outcome Measures
Extent and severity of a patient's spinal cord injury
ASIA Impairment Scale
Motor electrophysiology assessment
Evoked potentials
Somatosensory electrophysiology assessment
Evoked potentials
Electrical nerve stimulation on pain perception
Pain threshold perception
Mictional dysfunction
Urodynamic testing
Anal sphincter integrity
Anorectal manometry test
Neuropathic pain
Numerical scale (0 to 10)
Spasticity
Modified Ashworth scale
Functionality
SCIM III scale
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
Urinary disorder
Qualiveen questionnaire
Size injury
Magnetic Resonance Imaging
Presence of allogeneic cells
Chimerism in cerebrospinal fluid
Immunology
Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid
Full Information
NCT ID
NCT03003364
First Posted
December 14, 2016
Last Updated
February 13, 2020
Sponsor
Banc de Sang i Teixits
Collaborators
Hospital de Neurorehabilitació Institut Guttmann, Recerca Clínica S.L., Syntax for Science, S.L
1. Study Identification
Unique Protocol Identification Number
NCT03003364
Brief Title
Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 27, 2016 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
February 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Hospital de Neurorehabilitació Institut Guttmann, Recerca Clínica S.L., Syntax for Science, S.L
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XCEL-UMC-BETA/placebo
Arm Type
Experimental
Arm Description
Ex vivo cultured human mesenchymal stem cells from Wharton jelly, in a blinded syringe (initial treatment) / Placebo (month 6)
Arm Title
Placebo/XCEL-UMC-BETA
Arm Type
Placebo Comparator
Arm Description
Placebo in a blinded syringe (initial treatment) / XCEL-UMC-BETA (month 6)
Intervention Type
Drug
Intervention Name(s)
XCEL-UMC-BETA
Other Intervention Name(s)
Expanded MSC from Wharton Jelly
Intervention Description
Intrathecal allogeneic cell therapy in a blinded syringe
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in a blinded syringe
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
Adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Extent and severity of a patient's spinal cord injury
Description
ASIA Impairment Scale
Time Frame
6 months
Title
Motor electrophysiology assessment
Description
Evoked potentials
Time Frame
6 month
Title
Somatosensory electrophysiology assessment
Description
Evoked potentials
Time Frame
6 month
Title
Electrical nerve stimulation on pain perception
Description
Pain threshold perception
Time Frame
6 month
Title
Mictional dysfunction
Description
Urodynamic testing
Time Frame
6 month
Title
Anal sphincter integrity
Description
Anorectal manometry test
Time Frame
6 month
Title
Neuropathic pain
Description
Numerical scale (0 to 10)
Time Frame
6 months
Title
Spasticity
Description
Modified Ashworth scale
Time Frame
6 months
Title
Functionality
Description
SCIM III scale
Time Frame
6 months
Title
Quality of life (individual overall perception of quality of life, individual overall perception of their health, Physical health, Psychological, Social relationships, Environment)
Description
WHOQOL BREF questionnaire
Time Frame
6 months
Title
Urinary disorder
Description
Qualiveen questionnaire
Time Frame
6 months
Title
Size injury
Description
Magnetic Resonance Imaging
Time Frame
12 months
Title
Presence of allogeneic cells
Description
Chimerism in cerebrospinal fluid
Time Frame
1 month
Title
Immunology
Description
Antibodies anti-HLA in peripherical blood and in cerebrospinal fluid
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Vidal, MD, PhD
Organizational Affiliation
Hospital de Neurorehabilitació 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
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
derived
Links:
URL
http://bancsang.net/en_index/
Description
Blood and Tissue Bank of Catalonia
URL
http://www.guttmann.com/en
Description
Hospital de Neurorehabilitació Institut Guttmann
URL
http://www.ccma.cat/tv3/marato/en/
Description
Marató TV3
Learn more about this trial
Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury
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