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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.
The Da Vinci Center
George Town, Cayman Islands
Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 3 months
MS Impact Scale - MSIS-29
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 3 months
Modified SF-36 Cell-Based Therapy Follow Up
Modified SF-36 for Cell-Based Therapy Follow Up
Time frame: 3 months
Physical Evaluation
Vital signs of sitting blood pressure, temperature and heart rate
Time frame: 3 Months
MS Impact Scale - MSIS-29
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 6 months
MS Impact Scale - MSIS-29
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 1 year
Modified SF-36 Cell-Based Therapy Follow Up
Modified SF-36 for Cell-Based Therapy Follow Up
Time frame: 6 months
Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 6 months
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Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 1 year
Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 2 years
Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 3 years
Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 4 years
Standard Complication Questionnaire
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 5 years
Physical Evaluation
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 6 months
Physical Evaluation
incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed
Time frame: 1 Year