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Mesenchymal Stem Cell Transplantation in MS (CMM-EM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01228266
Recruitment Status : Terminated (Ended the recruitment in June 2012 for low enrollement accrual)
First Posted : October 26, 2010
Last Update Posted : February 13, 2014
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Albert Saiz, Hospital Clinic of Barcelona

Brief Summary:
The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: autologous mesenchymal stem cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study
Study Start Date : December 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: autologous mesenchymal stem cell
A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months
Biological: autologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS

Primary Outcome Measures :
  1. To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study [ Time Frame: 12 months ]
    The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI

Secondary Outcome Measures :
  1. To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales [ Time Frame: 12 months ]
    clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Inflammatory forms of MS

    1. Relapsing-remitting MS (RRMS) patients
    2. Secondary progressive MS (SPMS) patients with continued relapses
    3. Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
  2. Age 18-50 years
  3. Disease duration >= 2 and >= 10 years
  4. EDSS 3.0 - 6.5
  5. Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:

    1. Increase of >= 1 EDSS point (if baseline EDSS <= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression
    2. >= 1 moderate-severe relapses in past 18 months
    3. >= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
    4. >= 1 new T2 lesion
    5. For PPMS only, >= 1 Gadolinium enhancing lesions
  6. Has given informed consent to participate in the study.

Exclusion Criteria:

  1. SPMS without ongoing relapses
  2. PPMS without positive CSF or Gadolinium enhancing lesions
  3. <= 3 months since treatment with any immunosuppressive therapy
  4. <=1 month since last treatment with interferon-B or glatiramer acetate
  5. Corticosteroid treatment <= 30 days
  6. Relapse <= 60 days
  7. History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
  8. Any metallic or electronic device that precludes from undergoing MRI
  9. Pregnancy or lactation
  10. Current treatment with an investigational therapy

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 identifier (NCT number): NCT01228266

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Neurology Service, Hospital Clinic de barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Albert Saiz
Instituto de Salud Carlos III
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Principal Investigator: Albert Saiz, MD Hospital Clinic of Barcelona
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Albert Saiz, MD, Hospital Clinic of Barcelona Identifier: NCT01228266    
Other Study ID Numbers: CMM-EM
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Albert Saiz, Hospital Clinic of Barcelona:
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases