Back to results

Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

BMMNC

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring stem cell, Multiple Sclerosis, BMMNC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BMMNC

Arm Description

Administration of of Bone Marrow derived Mono Nuclear Stem Cell (MNCs)

Outcomes

Primary Outcome Measures

analysis of patients symptoms

Improvement in patients symptoms

Secondary Outcome Measures

changes in Expanded Kurtzke Disability Status Score scale

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

Quality Of life questionnaire

changes in MRI scan report

changes in cerebrospinal fluid tests

Changes in analysis of visual evoked potential test

Full Information

NCT ID

NCT01883661

First Posted

June 12, 2013

Last Updated

September 16, 2014

Sponsor

Chaitanya Hospital, Pune

1. Study Identification

Unique Protocol Identification Number

NCT01883661

Brief Title

Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

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 Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

June 2014 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

stem cell, Multiple Sclerosis, BMMNC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BMMNC

Arm Type

Other

Arm Description

Administration of of Bone Marrow derived Mono Nuclear Stem Cell (MNCs)

Intervention Type

Biological

Intervention Name(s)

BMMNC

Intervention Description

Bone Marrow derived Mono Nuclear Stem Cell (MNCs) by intravenously route total 3 doses in one month period .

Primary Outcome Measure Information:

Title

analysis of patients symptoms

Description

Improvement in patients symptoms

Time Frame

baseline and 6 months

Secondary Outcome Measure Information:

Title

changes in Expanded Kurtzke Disability Status Score scale

Description

The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.the evaluation will be done after 6 month

Time Frame

baseline and 6 months

Title

changes in clinical variables

Time Frame

baseline and 6 months

Title

Quality Of life questionnaire

Time Frame

baseline and 6 months

Title

changes in MRI scan report

Time Frame

baseline and 6 months

Title

changes in cerebrospinal fluid tests

Time Frame

baseline and 6 months

Title

Changes in analysis of visual evoked potential test

Time Frame

baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sachin P Jamadar, D.Ortho

Phone

918888788880

sac2751982@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ANANT E BAGUL, MS ORTHO

Organizational Affiliation

Chaitanya Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chaitanya Hospital

City

Pune,

State/Province

Maharashtra

ZIP/Postal Code

411009

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sachin P Jamadar, D ORTHO

Phone

+918888788880

anantbagul@yahoo.com

First Name & Middle Initial & Last Name & Degree

Anant E Bagul, MS,Ortho

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

We'll reach out to this number within 24 hrs