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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02326935
Recruitment Status : Terminated
First Posted : December 30, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
American CryoStem Corporation

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Autologous adipose derived mesenchymal cells Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : May 18, 2018
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adipose derived mesenchymal cells

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
Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.
Other Name: ADSC, mesenchymal cells, stromal cells




Primary Outcome Measures :
  1. Standard Complication Questionnaire [ Time Frame: 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

  2. MS Impact Scale - MSIS-29 [ Time Frame: 3 months ]
    Multiple Sclerosis Impact Scale (MSIS-29)

  3. Modified SF-36 Cell-Based Therapy Follow Up [ Time Frame: 3 months ]
    Modified SF-36 for Cell-Based Therapy Follow Up

  4. Physical Evaluation [ Time Frame: 3 Months ]
    Vital signs of sitting blood pressure, temperature and heart rate


Secondary Outcome Measures :
  1. MS Impact Scale - MSIS-29 [ Time Frame: 6 months ]
    Multiple Sclerosis Impact Scale (MSIS-29)

  2. MS Impact Scale - MSIS-29 [ Time Frame: 1 year ]
    Multiple Sclerosis Impact Scale (MSIS-29)

  3. Modified SF-36 Cell-Based Therapy Follow Up [ Time Frame: 6 months ]
    Modified SF-36 for Cell-Based Therapy Follow Up

  4. Standard Complication Questionnaire [ Time Frame: 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

  5. Standard Complication Questionnaire [ Time Frame: 1 year ]
    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. Standard Complication Questionnaire [ Time Frame: 2 years ]
    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

  7. Standard Complication Questionnaire [ Time Frame: 3 years ]
    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

  8. Standard Complication Questionnaire [ Time Frame: 4 years ]
    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

  9. Standard Complication Questionnaire [ Time Frame: 5 years ]
    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

  10. Physical Evaluation [ Time Frame: 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

  11. Physical Evaluation [ Time Frame: 1 Year ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326935


Locations
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Cayman Islands
The Da Vinci Center
George Town, Cayman Islands, KY1-1205
Sponsors and Collaborators
American CryoStem Corporation
Investigators
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Principal Investigator: Louis A Cona, MD The Da Vinci Center

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Responsible Party: American CryoStem Corporation
ClinicalTrials.gov Identifier: NCT02326935     History of Changes
Other Study ID Numbers: CRYO-MS-ADSC-006
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by American CryoStem Corporation:
MS
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Myelitis

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases