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Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT01883661
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : June 21, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Study Description
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Brief Summary:
The aim of this study is to prove the BMMNC Therapy in Multiple sclerosis, and to control symptoms and help to maintain a normal quality of life of suffering patients.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: BMMNC Phase 1 Phase 2

Detailed Description:
Multiple sclerosis (MS) is considered to be an autoimmune disease that is caused by the immune system attacking the central nervous system (CNS) leading to myelin loss and axonal damage, resulting in long-term disability. The pathophysiology of MS is complex with involvement of genetic and environmental factors that define the susceptibility to generate the autoimmune attack. MS is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. When this nerve covering is damaged, nerve signals slow down or stop.The nerve damage is caused by inflammation. Inflammation occurs when the body's own immune cells attack the nervous system. Currently, treatment of MS relays mainly on immunosuppression combined with monoclonal antibodies and steroid therapies.The most advanced application for MSCs in the neurological clinical arena is in multiple sclerosis.This clinical study time period is for 1 year. This study is carried out to see the role of BMMNC cell Therapy in Multiple sclerosis, and to control symptoms and help to maintain a normal quality of life of suffering patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
BMMNC
Administration of of Bone Marrow derived Mono Nuclear Stem Cell (MNCs)
 Biological: BMMNC
Bone Marrow derived Mono Nuclear Stem Cell (MNCs) by intravenously route total 3 doses in one month period .


Outcome Measures
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Primary Outcome Measures :
  1. analysis of patients symptoms [ Time Frame: baseline and 6 months ]
    Improvement in patients symptoms


Secondary Outcome Measures :
  1. changes in Expanded Kurtzke Disability Status Score scale [ Time Frame: baseline and 6 months ]
    The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.the evaluation will be done after 6 month

  2. changes in clinical variables [ Time Frame: baseline and 6 months ]
  3. Quality Of life questionnaire [ Time Frame: baseline and 6 months ]
  4. changes in MRI scan report [ Time Frame: baseline and 6 months ]
  5. changes in cerebrospinal fluid tests [ Time Frame: baseline and 6 months ]
  6. Changes in analysis of visual evoked potential test [ Time Frame: baseline and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
Contacts and Locations
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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): NCT01883661


Contacts
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Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com

Locations
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India
Chaitanya Hospital Recruiting
Pune,, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    +918888788880    anantbagul@yahoo.com   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
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Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
More Information
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Responsible Party: Dr. Sachin Jamadar, Sub Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01883661     History of Changes
Other Study ID Numbers: CSCC/BM/2013/MS/01
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
stem cell
Multiple Sclerosis
BMMNC
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases