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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
Banc de Sang i Teixits
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 3, 2015
Last Updated
January 15, 2020
Sponsor
Banc de Sang i Teixits
Collaborators
Vall d'Hebron Research Institute (VHIR)
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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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