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Trial record 48 of 75 for:    stem cell multiple sclerosis

Autologous Mesenchymal Stromal Cells for Multiple Sclerosis (EMMES)

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ClinicalTrials.gov Identifier: NCT02495766
Recruitment Status : Active, not recruiting
First Posted : July 13, 2015
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Vall d'Hebron Research Institute (VHIR)
Information provided by (Responsible Party):
Banc de Sang i Teixits

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.


Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Drug: XCEL-MC-ALPHA Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : November 27, 2017
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Bone-marrow mesenchymal stromal cells

Drug: Placebo
Single infusion




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    Safety profile


Secondary Outcome Measures :
  1. Cumulative number of MRI Gd-enhancing lesions [ Time Frame: 12 months ]
    Imaging procedure

  2. Multiple Sclerosis Outbreaks [ Time Frame: 12 months ]
    Medical assessment

  3. Expanded Disability Status Scale (EDDS) score [ Time Frame: 12 months ]
    Quantification of disability

  4. Cumulative number of lesions visualized on T2 sequence [ Time Frame: 12 months ]
    Imaging procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495766


Locations
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Spain
Hospital Vall Hebron
Barcelona, Spain, 08005
Sponsors and Collaborators
Banc de Sang i Teixits
Vall d'Hebron Research Institute (VHIR)
Investigators
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Principal Investigator: Xavier Montalban, MD, PhD Hospital Vall d'Hebron

Additional Information:
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Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT02495766     History of Changes
Other Study ID Numbers: XCEL-MS-02
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Keywords provided by Banc de Sang i Teixits:
Multiple sclerosis
Bone marrow mesenchymal stromal cells
Stem cells
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases