Mesenchymal Stem Cell Transplantation in MS (CMM-EM)

This study has been terminated.
(Ended the recruitment in June 2012 for low enrollement accrual)
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Albert Saiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01228266
First received: October 25, 2010
Last updated: February 12, 2014
Last verified: February 2014

October 25, 2010
February 12, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01228266
CMM-EM
No
Albert Saiz, Hospital Clinic of Barcelona
Albert Saiz
Instituto de Salud Carlos III
Principal Investigator: Albert Saiz, MD Hospital Clinic de 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