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Trial record 31 of 76 for:    stem cell multiple sclerosis

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

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 30, 2014
Last Update Posted Date May 22, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • 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
  • MS Impact Scale - MSIS-29 [ Time Frame: 3 months ]
    Multiple Sclerosis Impact Scale (MSIS-29)
  • Modified SF-36 Cell-Based Therapy Follow Up [ Time Frame: 3 months ]
    Modified SF-36 for Cell-Based Therapy Follow Up
  • Physical Evaluation [ Time Frame: 3 Months ]
    Vital signs of sitting blood pressure, temperature and heart rate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02326935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • MS Impact Scale - MSIS-29 [ Time Frame: 6 months ]
    Multiple Sclerosis Impact Scale (MSIS-29)
  • MS Impact Scale - MSIS-29 [ Time Frame: 1 year ]
    Multiple Sclerosis Impact Scale (MSIS-29)
  • Modified SF-36 Cell-Based Therapy Follow Up [ Time Frame: 6 months ]
    Modified SF-36 for Cell-Based Therapy Follow Up
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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
Study Arms  ICMJE 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

Intervention: Biological: Autologous adipose derived mesenchymal cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 18, 2018)
2
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2014)
100
Actual Study Completion Date  ICMJE May 18, 2018
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cayman Islands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326935
Other Study ID Numbers  ICMJE CRYO-MS-ADSC-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party American CryoStem Corporation
Study Sponsor  ICMJE American CryoStem Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Louis A Cona, MD The Da Vinci Center
PRS Account American CryoStem Corporation
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP