Study to Evaluate Therapy for Patients With Secondary Progressive Multiple Sclerosis, Using the Patient’s Own Stem Cells From Fat

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What? Phase I and II study evaluating the safety and feasibility of regenerative therapy with the patient's own stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who have not responded to treatment.

Where? Participants receive care at the following locations:

• Hospital Regional Universitario Carlos Haya, Málaga, Spain
• Hospital Universitario Virgen Macarena, Sevilla, Spain.

Why? The main purpose of this study is to evaluate the safety and feasibility of therapy with the patient's own stem cells from fat, administered intravenously in patients with secondary progressive multiple sclerosis, who have not responded to treatment.

How? Patients will experience a mini-liposuction of abdominal fat. Stem cells will be derived from that fat and administered intravenously to the patient.

When? This study is currently accepting patients. Patients will be observed over 12 months following the procedure.

Who may participate? Patients must meet the following criteria:

1. Patient must be 18 years of age or older.
2. Patients diagnosed with Multiple Sclerosis (MS).
3. Secondary progressive MS patients with EDSS of more than 5.5 and less than 9.
4. 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.
5. Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
6. Patients who give written consent to participate in the study.

Who may not participate? Patients may not participate if they meet the following 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 of more than 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.

For more information:
Ana - Cardesa
Phone: 011-34-95-501-90-40