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Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01056471
First received: January 25, 2010
Last updated: August 4, 2015
Last verified: February 2015
History of Changes
January 25, 2010
August 4, 2015
January 2010
June 2012   (Final data collection date for primary outcome measure)
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells [ Time Frame: 12 months. ]
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells [ Time Frame: 24 hr, 8 days, 1, 2, 3, 6, 9 and 12 months. ]
Complete list of historical versions of study NCT01056471 on ClinicalTrials.gov Archive Site
To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales. [ Time Frame: 12 months ]
To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales. [ Time Frame: 24 hr, 8 days, 1, 2, 3, 6, 9 and 12 months ]
Not Provided
Not Provided
 
Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Autoimmune Diseases
  • Immune System Diseases
  • Demyelinating Diseases
  • Nervous System Diseases
  • Demyelinating Autoimmune Diseases, CNS
  • Autoimmune Diseases of the Nervous System
  • Other: Autologous mesenchymal stem cells from adipose tissue.
    Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.
  • Other: Autologous mesenchymal stem cells from adipose tissue.
    Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
  • Experimental: Low dose autologous mesenchymal cells
    The dose of infused cells is 10e6 cells/Kg
    Intervention: Other: Autologous mesenchymal stem cells from adipose tissue.
  • Experimental: High dose
    The dose of infused cells is 4*10e6 cells/Kg
    Intervention: Other: Autologous mesenchymal stem cells from adipose tissue.
  • No Intervention: Placebo Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2015
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
  2. Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
  3. Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
  4. Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
  5. Patients who give written consent to participate in the study. -

Exclusion Criteria:

  1. History of current pathology or current laboratory results indicative of any severe disease.
  2. Pacemaker or metallic implants that prevent MR imaging.
  3. Inability to complete questionnaires.
  4. Refusal to give informed consent.
  5. Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
  6. Positive screening test for HIV, Hepatitis B or Hepatitis C.
  7. History of malignancy.
  8. Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
  9. Body mass index> 40 kg/m2.
  10. Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.

  11. Pregnancy or lactation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01056471
CMM/EM/2008
No
Not Provided
Not Provided
Not Provided
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Carlos III Health Institute
Study Director: Oscar Fernandez Fernandez, MD, PhD Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Principal Investigator: Guillermo Izquierdo Ayuso, MD, PhD Hospital Universitario Virgen Macarena, Sevilla, Spain
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
February 2015

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