Multiple Sclerosis Clinical Trial
Official title:
Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis
The intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 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 ADSC
implantation using an IV delivery system. The study will provide therapies to up to 100
qualified patients who match the inclusion/exclusion criteria, agree to the follow up program
and who have provided a signed consent for each procedure.
The treatment is a combination of (a) general detoxification, (b) lymphatic massage/drainage,
(c) therapeutic massage, reflexology and acupuncture and (d) cellular infusion therapy in
which cells will be deployed via IV injection over two treatments of 60 minutes each during
the five (5) day treatment period.
Follow-up data based upon MSIS-29, a modified SF-36 and standard complication questionnaire
will be collected at 3, 6 and then annually post treatment by the patients' local physician
and reported back to the sponsor where it will be logged into a HIPPA-compliant outcomes
database.
Additional safety data, based upon a standard complication questionnaire will be collected
via survey of patient at intervals of 3 and 6 months and then annually for a minimum of five
(5) years.
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