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The intent of this clinical study is to answer the questions:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose SVF IV Infusion | Experimental | IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting and Implantation of SVF | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement in disability score compared to baseline | 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. | up to 6 months |
| Clinical improvement in disability score compared to baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MS disease activity measured by the number of Gd-enhancing brain MRI lesions | 3 months | |
| Reduced number of relapses or freedom from progression of disease | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon McQuillan, MD | Ageless Regenerative Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageless Regenerative Institute LLC | Aventura | Florida | 33180 | United States |
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| Reduced number of relapses or freedom from progression of disease |
| 6 months |
| MS disease activity measured by the number of Gd-enhancing brain MRI lesions | 6 months |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D001327 | Autoimmune Diseases |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D003711 | Demyelinating Diseases |
| D007154 | Immune System Diseases |
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