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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose derived mesenchymal cells | Experimental | Intervention: Autologous adipose derived mesenechymal stem cells, 150 million cells deployed via two (2) treatments via intravenous injection Other Names: ADSC, mesenchymal cells, stromal cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous adipose derived mesenchymal cells | Biological | Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| MS Impact Scale - MSIS-29 | Multiple Sclerosis Impact Scale (MSIS-29) | 3 months |
| Modified SF-36 Cell-Based Therapy Follow Up | Modified SF-36 for Cell-Based Therapy Follow Up | 3 months |
| Physical Evaluation | Vital signs of sitting blood pressure, temperature and heart rate | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| MS Impact Scale - MSIS-29 | Multiple Sclerosis Impact Scale (MSIS-29) | 6 months |
| MS Impact Scale - MSIS-29 | Multiple Sclerosis Impact Scale (MSIS-29) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis A Cona, MD | The Da Vinci Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Da Vinci Center | George Town | KY1-1205 | Cayman Islands |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009187 | Myelitis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| 1 year |
| Modified SF-36 Cell-Based Therapy Follow Up | Modified SF-36 for Cell-Based Therapy Follow Up | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 1 Year |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |