The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes?
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation performed intrathecally and intravenously. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The cell therapy in this study is composed of stem cells derived from a patient's own adipose tissue that are harvested by liposuction using tumescent technique and isolated in the laboratory. The Adipose SVF will be delivered via intravenous injection.
Ageless Regenerative Institute LLC
Aventura, Florida, United States
Clinical improvement in disability score compared to baseline
Time frame: 3 months
Number of patients with adverse events
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Time frame: up to 6 months
Clinical improvement in disability score compared to baseline
Time frame: 6 months
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Time frame: 3 months
Reduced number of relapses or freedom from progression of disease
Time frame: 3 months
Reduced number of relapses or freedom from progression of disease
Time frame: 6 months
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
Time frame: 6 months
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