Autologous Mesenchymal Stromal Cells for Multiple Sclerosis (EMMES)

January 15, 2020 updated by: Banc de Sang i Teixits

Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08005
        • Hospital Vall Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment A: XCEL-MC-ALPHA/Placebo
Single infusion of cryopreserved bone-marrow adult mesenchymal stromal cells followed by placebo infusion at month 6.
Drug: XCEL-MC-ALPHA
Single infusion
Other Names:
  • Bone-marrow mesenchymal stromal cells
Drug: Placebo
Single infusion
EXPERIMENTAL: Treatment B: Placebo/XCEL-MC-ALPHA
Single infusion of placebo followed by cryopreserved bone-marrow adult mesenchymal stromal cells infusion at month 6.
Drug: XCEL-MC-ALPHA
Single infusion
Other Names:
  • Bone-marrow mesenchymal stromal cells
Drug: Placebo
Single infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 months
Safety profile
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative number of MRI Gd-enhancing lesions
Time Frame: 12 months
Imaging procedure
12 months
Multiple Sclerosis Outbreaks
Time Frame: 12 months
Medical assessment
12 months
Expanded Disability Status Scale (EDDS) score
Time Frame: 12 months
Quantification of disability
12 months
Cumulative number of lesions visualized on T2 sequence
Time Frame: 12 months
Imaging procedure
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banc de Sang i Teixits

Collaborators

Vall d'Hebron Research Institute (VHIR)

Investigators

  • Principal Investigator: Xavier Montalban, MD, PhD, Hospital Vall d'hebrón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2015

Primary Completion (ACTUAL)

November 27, 2017

Study Completion (ACTUAL)

November 15, 2018

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (ESTIMATE)

July 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCEL-MS-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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