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Mesenchymal Stem Cell Transplantation in MS (CMM-EM)

This study has been terminated.
(Ended the recruitment in June 2012 for low enrollement accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228266
First Posted: October 26, 2010
Last Update Posted: February 13, 2014
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.
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Albert Saiz, Hospital Clinic of Barcelona
October 25, 2010
October 26, 2010
February 13, 2014
December 2010
June 2013   (Final data collection date for primary outcome measure)
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
To evaluate the safety and tolerability of autologous mesenchymal stem cell [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01228266 on ClinicalTrials.gov Archive Site
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
To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Mesenchymal Stem Cell Transplantation in MS
Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
Biological: autologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
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
Intervention: Biological: autologous mesenchymal stem cells
Llufriu S, Sepúlveda M, Blanco Y, Marín P, Moreno B, Berenguer J, Gabilondo I, Martínez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernández B, Bullich S, Sánchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
December 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01228266
CMM-EM
No
Not Provided
Not Provided
Albert Saiz, Hospital Clinic of Barcelona
Albert Saiz
Instituto de Salud Carlos III
Principal Investigator: Albert Saiz, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP