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Trial record 32 of 75 for:    stem cell multiple sclerosis

Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

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: 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

Tracking Information
First Submitted Date  ICMJE June 12, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
analysis of patients symptoms [ Time Frame: baseline and 6 months ]
Improvement in patients symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Improvement in analysis of patients symptoms [ Time Frame: baseline and 6 months ]
Improvement in patients symptoms
Change History Complete list of historical versions of study NCT01883661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • 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
  • changes in clinical variables [ Time Frame: baseline and 6 months ]
  • Quality Of life questionnaire [ Time Frame: baseline and 6 months ]
  • changes in MRI scan report [ Time Frame: baseline and 6 months ]
  • changes in cerebrospinal fluid tests [ Time Frame: baseline and 6 months ]
  • Changes in analysis of visual evoked potential test [ Time Frame: baseline and 6 months ]
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 Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Biological: BMMNC
Bone Marrow derived Mono Nuclear Stem Cell (MNCs) by intravenously route total 3 doses in one month period .
Study Arms  ICMJE BMMNC
Administration of of Bone Marrow derived Mono Nuclear Stem Cell (MNCs)
Intervention: Biological: BMMNC
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date November 2016   (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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883661
Other Study ID Numbers  ICMJE CSCC/BM/2013/MS/01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sachin Jamadar, Chaitanya Hospital, Pune
Study Sponsor  ICMJE Chaitanya Hospital, Pune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
PRS Account Chaitanya Hospital, Pune
Verification Date September 2014

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