Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Biological: Autologous adipose derived mesenchymal cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed Diagnosis of MS Aged 18 - 65 years. Duration of disease: >5 years Signed, written informed consent willing and able to comply with study visits according to protocol for the full study period Physically, mentally and legally capable of international travel for treatment Exclusion Criteria: Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results Patient with any active or chronic infection No life-threatening organ dysfunction. Pregnancy or risk of pregnancy. Severe physical limitations or disabilities Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C Patients unable to give written informed consent in accordance with research ethics board guidelines Treatment with any immunosuppressive therapy within the 3 months prior to randomization Current treatment with an investigational therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose derived mesenchymal cells<br>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 | Biological: Autologous adipose derived mesenchymal cells<br>* Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.<br>* Other names: ADSC, mesenchymal cells, stromal cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Myelitis