Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

September 16, 2014 updated by: Dr. Sachin Jamadar, Chaitanya Hospital, Pune

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune,, Maharashtra, India, 411009
        • Recruiting
        • Chaitanya Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analysis of patients symptoms
Time Frame: baseline and 6 months
Improvement in patients symptoms
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 6 months
changes in clinical variables
Time Frame: baseline and 6 months
baseline and 6 months
Quality Of life questionnaire
Time Frame: baseline and 6 months
baseline and 6 months
changes in MRI scan report
Time Frame: baseline and 6 months
baseline and 6 months
changes in cerebrospinal fluid tests
Time Frame: baseline and 6 months
baseline and 6 months
Changes in analysis of visual evoked potential test
Time Frame: baseline and 6 months
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chaitanya Hospital, Pune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSCC/BM/2013/MS/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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