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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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19 February 2015 |
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Main ID: |
NCT01883661 |
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Date of registration:
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12/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)
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Scientific title:
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Role of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (MNCs) In Patient With Multiple Sclerosis .It is Self Funded (Patients' Own Funding) Clinical Trial |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01883661 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Sachin P Jamadar, D.Ortho |
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Address:
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Telephone:
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918888788880 |
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Email:
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sac2751982@gmail.com |
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Affiliation:
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Name:
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Sachin P Jamadar, D ORTHO |
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Address:
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Telephone:
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+918888788880 |
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Email:
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anantbagul@yahoo.com |
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Affiliation:
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Name:
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ANANT E BAGUL, MS ORTHO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chaitanya Hospital |
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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
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.
- 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, including natalizumab and fingolimod,
within the 3 months prior to randomization
- Treatment with interferon-beta or glatiramer acetate within the 30 days prior to
randomization
- Treatment with corticosteroids within the 30 days prior to randomization
- Current treatment with an investigational therapy
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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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: BMMNC
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Primary Outcome(s)
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analysis of patients symptoms
[Time Frame: baseline and 6 months]
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Secondary Outcome(s)
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changes in cerebrospinal fluid tests
[Time Frame: baseline and 6 months]
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changes in clinical variables
[Time Frame: baseline and 6 months]
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changes in Expanded Kurtzke Disability Status Score scale
[Time Frame: baseline and 6 months]
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Changes in analysis of visual evoked potential test
[Time Frame: baseline and 6 months]
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Quality Of life questionnaire
[Time Frame: baseline and 6 months]
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changes in MRI scan report
[Time Frame: baseline and 6 months]
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Secondary ID(s)
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CSCC/BM/2013/MS/01
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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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