An interventional study of Harvesting and Implantation of SVF in Multiple Sclerosis, Autoimmune Diseases and Autoimmune Diseases of the Nervous System, sponsored by Ageless Regenerative Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by Ageless Regenerative Institute · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
IV Infusion of Autologous Adipose Derived Stromal Vascular Fraction Intervention: Intravenous Infusion
Procedure: Harvesting and Implantation of SVF
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Ageless Regenerative Institute