Trial | NCT02326935  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    2
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 Started
Nov 30
2014
Primary Completion
May 18
2018
Study Completion
May 18
2018
Last Update
May 22
2018

Biological Autologous adipose derived mesenchymal cells

Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.

  • Other names: ADSC, mesenchymal cells, stromal cells

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

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
No Results Posted