Clinical trial NCT02326935: Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: MS
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Myelitis
Lead sponsor: American CryoStem Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Standard Complication Questionnaire
timeFrame: 3 months
measure: MS Impact Scale - MSIS-29
timeFrame: 3 months
measure: Modified SF-36 Cell-Based Therapy Follow Up
timeFrame: 3 months
measure: Physical Evaluation
timeFrame: 3 Months
Secondary outcomes:
measure: MS Impact Scale - MSIS-29
timeFrame: 6 months
measure: MS Impact Scale - MSIS-29
timeFrame: 1 year
measure: Modified SF-36 Cell-Based Therapy Follow Up
timeFrame: 6 months
measure: Standard Complication Questionnaire
timeFrame: 6 months
measure: Standard Complication Questionnaire
timeFrame: 1 year
measure: Standard Complication Questionnaire
timeFrame: 2 years
measure: Standard Complication Questionnaire
timeFrame: 3 years
measure: Standard Complication Questionnaire
timeFrame: 4 years
measure: Standard Complication Questionnaire
timeFrame: 5 years
measure: Physical Evaluation
timeFrame: 6 months
measure: Physical Evaluation
timeFrame: 1 Year
Other outcomes:
Locations:
city: George Town
country: Cayman Islands
facility: The Da Vinci Center
Study officials:
affiliation: The Da Vinci Center
name: Louis A Cona, MD
role: PRINCIPAL_INVESTIGATOR
References: