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

Sponsor: 
Fundacion Progreso y Salud
Location: 

Hospital Regional Universitario Carlos Haya, Málaga, Spain

Hospital Universitario Virgen Macarena, Sevilla, Spain

Country: 
Spain

The main purpose of this study is to evaluate the safety and feasibility of stem cell therapy with mesenchymal stem cells taken from adipose tissue, givenintravenously in patients with secondary progressive multiple sclerosis  patients who do not otherwise respond to treatment.

Eligible Ages for Trial: 
18-99
Eligible Genders for Trial: 
Both
Illness: 
Multiple Sclerosis

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 as no response to immunomodulators / immunosuppressants, and showing activity in the form of one relapse in the last year or 0.5 points in EDSS progression.
  4. Patients with without an MS relapse and no steroid treatment in the month before  inclusion.
  5. Patients who have give written consent to participate in the study.

Exclusion Criteria:

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

 

January 1, 2010 - June 1, 2012
Trial Status: 
Recruiting
Contact: 
Ana - Cardesa 0034 95 501 90 40

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