Multiple Sclerosis
Conditions
Keywords
MS, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Myelitis
Brief summary
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
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.
Interventions
BIOLOGICALAutologous adipose derived mesenchymal cells
Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.
Sponsors
American CryoStem Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Complication Questionnaire | 3 months | 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 |
| MS Impact Scale - MSIS-29 | 3 months | Multiple Sclerosis Impact Scale (MSIS-29) |
| Modified SF-36 Cell-Based Therapy Follow Up | 3 months | Modified SF-36 for Cell-Based Therapy Follow Up |
| Physical Evaluation | 3 Months | Vital signs of sitting blood pressure, temperature and heart rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MS Impact Scale - MSIS-29 | 6 months | Multiple Sclerosis Impact Scale (MSIS-29) |
| Modified SF-36 Cell-Based Therapy Follow Up | 6 months | Modified SF-36 for Cell-Based Therapy Follow Up |
| Standard Complication Questionnaire | 6 months | 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 |
| Physical Evaluation | 6 months | 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 |
Countries
Cayman Islands
Outcome results
None listed