Autologous Mesenchymal Stromal Cells for Multiple Sclerosis (EMMES)
Primary Purpose
Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
XCEL-MC-ALPHA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Multiple sclerosis, Bone marrow mesenchymal stromal cells, Stem cells, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 and 60 years of age
- Patients with MS
- Relapsing-remitting or secondary progressive MS
- Patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs
- Expanded Disability Status Scale (EDDS) score <6.5
- Nine T2 lesions at least
- Active multiple sclerosis as defined either by 1 outbreak in the last year or at least one Gadolinium-enhancing lesion in the last 6 months
- Signed informed consent form
Exclusion Criteria:
- Interferon beta or glatiramer acetate 3 months prior the screening
- Natalizumab or fingolimod in the 6 months prior the screening
- Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
- Has received an experimental treatment within 3 months prior the screening
- MS outbreak within the 4 weeks prior the randomization
- Serum creatinine> 2.0 mg/dl
- Infectious disease active or uncontrolled
- Fertile patients who are not using a suitable method of contraception
- Pregnant or lactating woman
- Immunodeficiency
- Positive serology to HIV, Hepatitis B, Hepatitis C or syphilis
Sites / Locations
- Hospital Vall Hebron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment A: XCEL-MC-ALPHA/Placebo
Treatment B: Placebo/XCEL-MC-ALPHA
Arm Description
Single infusion of cryopreserved bone-marrow adult mesenchymal stromal cells followed by placebo infusion at month 6.
Single infusion of placebo followed by cryopreserved bone-marrow adult mesenchymal stromal cells infusion at month 6.
Outcomes
Primary Outcome Measures
Adverse events
Safety profile
Secondary Outcome Measures
Cumulative number of MRI Gd-enhancing lesions
Imaging procedure
Multiple Sclerosis Outbreaks
Medical assessment
Expanded Disability Status Scale (EDDS) score
Quantification of disability
Cumulative number of lesions visualized on T2 sequence
Imaging procedure
Full Information
NCT ID
NCT02495766
First Posted
June 3, 2015
Last Updated
January 15, 2020
Sponsor
Banc de Sang i Teixits
Collaborators
Vall d'Hebron Research Institute (VHIR)
1. Study Identification
Unique Protocol Identification Number
NCT02495766
Brief Title
Autologous Mesenchymal Stromal Cells for Multiple Sclerosis
Acronym
EMMES
Official Title
Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2015 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
November 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Vall d'Hebron Research Institute (VHIR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.
Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6, the treatment will be crossed to receive the other product. The objective is to assess the safety of a single infusion BM-MSC, and to explore its efficacy in these patients.
Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.
Detailed Description
To date, there is no effective therapy to cure multiple sclerosis (MS). Immunomodulatory therapies are useful in reducing the frequency of inflammatory processes (relapses) but don't delay significantly the progression of the disease, prevent long term disability or induce the repair of damaged tissue. This proposal contemplates the use of adult autologous bone marrow mesenchymal stromal cells (BM-MSC) as an alternative therapeutic strategy to treat patients with active MS. This is a randomized, double blind, crossover clinical trial in which 8 patients with active forms of MS and moderate disability will enter the trial with the primary objective of assessing the safety and tolerability of a single intravenous infusion of BM-MSC. Secondary objectives are to assess the efficacy by gadolinium enhancing lesions though magnetic resonance imaging, neurophysiological effects and immunological effects. Once randomized, patients will undergo BM extraction and once confirmed the availability of the needed dose, they will be randomized to one of the 2 treatment arms (BM-MSC named XCEL-MC-ALPHA, or placebo). XCEL-MC-ALPHA will be cryopreserved for all patients regardless the allocated arm. At month 6, the treatment will be crossed. Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Keywords
Multiple sclerosis, Bone marrow mesenchymal stromal cells, Stem cells, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A: XCEL-MC-ALPHA/Placebo
Arm Type
Experimental
Arm Description
Single infusion of cryopreserved bone-marrow adult mesenchymal stromal cells followed by placebo infusion at month 6.
Arm Title
Treatment B: Placebo/XCEL-MC-ALPHA
Arm Type
Experimental
Arm Description
Single infusion of placebo followed by cryopreserved bone-marrow adult mesenchymal stromal cells infusion at month 6.
Intervention Type
Drug
Intervention Name(s)
XCEL-MC-ALPHA
Other Intervention Name(s)
Bone-marrow mesenchymal stromal cells
Intervention Description
Single infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single infusion
Primary Outcome Measure Information:
Title
Adverse events
Description
Safety profile
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cumulative number of MRI Gd-enhancing lesions
Description
Imaging procedure
Time Frame
12 months
Title
Multiple Sclerosis Outbreaks
Description
Medical assessment
Time Frame
12 months
Title
Expanded Disability Status Scale (EDDS) score
Description
Quantification of disability
Time Frame
12 months
Title
Cumulative number of lesions visualized on T2 sequence
Description
Imaging procedure
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 18 and 60 years of age
Patients with MS
Relapsing-remitting or secondary progressive MS
Patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs
Expanded Disability Status Scale (EDDS) score <6.5
Nine T2 lesions at least
Active multiple sclerosis as defined either by 1 outbreak in the last year or at least one Gadolinium-enhancing lesion in the last 6 months
Signed informed consent form
Exclusion Criteria:
Interferon beta or glatiramer acetate 3 months prior the screening
Natalizumab or fingolimod in the 6 months prior the screening
Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
Has received an experimental treatment within 3 months prior the screening
MS outbreak within the 4 weeks prior the randomization
Serum creatinine> 2.0 mg/dl
Infectious disease active or uncontrolled
Fertile patients who are not using a suitable method of contraception
Pregnant or lactating woman
Immunodeficiency
Positive serology to HIV, Hepatitis B, Hepatitis C or syphilis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Montalban, MD, PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Vall Hebron
City
Barcelona
ZIP/Postal Code
08005
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.bancsang.net
Description
Blood and Tissue Bank of Catalonia
URL
http://www.cem-cat.org/
Description
Multiple Sclerosis center of Catalonia
URL
http://www.vhir.org
Description
Vall d'Hebron Research Institute
Learn more about this trial
Autologous Mesenchymal Stromal Cells for Multiple Sclerosis
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