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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02326935 |
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Date of registration:
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18/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis
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Scientific title:
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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 |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02326935 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Cayman Islands
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Contacts
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Name:
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Louis A Cona, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Da Vinci Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Biological: Autologous adipose derived mesenchymal cells
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Primary Outcome(s)
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Modified SF-36 Cell-Based Therapy Follow Up
[Time Frame: 3 months]
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Physical Evaluation
[Time Frame: 3 Months]
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Standard Complication Questionnaire
[Time Frame: 3 months]
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MS Impact Scale - MSIS-29
[Time Frame: 3 months]
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Secondary Outcome(s)
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Standard Complication Questionnaire
[Time Frame: 5 years]
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MS Impact Scale - MSIS-29
[Time Frame: 1 year]
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Standard Complication Questionnaire
[Time Frame: 2 years]
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Modified SF-36 Cell-Based Therapy Follow Up
[Time Frame: 6 months]
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MS Impact Scale - MSIS-29
[Time Frame: 6 months]
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Physical Evaluation
[Time Frame: 6 months]
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Standard Complication Questionnaire
[Time Frame: 1 year]
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Standard Complication Questionnaire
[Time Frame: 6 months]
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Physical Evaluation
[Time Frame: 1 Year]
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Standard Complication Questionnaire
[Time Frame: 3 years]
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Standard Complication Questionnaire
[Time Frame: 4 years]
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Secondary ID(s)
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CRYO-MS-ADSC-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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