Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

Phase 1

• Conditions: Multiple Sclerosis
• Interventions: Biological: BMMNC

• Registration Number: NCT01883661
• Lead Sponsor: Chaitanya Hospital, Pune

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 Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Study Start: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMMNC	BMMNC	Administration of of Bone Marrow derived Mono Nuclear Stem Cell (MNCs)

Primary Outcome Measures

Name	Time	Method
analysis of patients symptoms	baseline and 6 months	Improvement in patients symptoms

Secondary Outcome Measures

Name	Time	Method
changes in Expanded Kurtzke Disability Status Score scale	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	baseline and 6 months
Quality Of life questionnaire	baseline and 6 months
changes in MRI scan report	baseline and 6 months
changes in cerebrospinal fluid tests	baseline and 6 months
Changes in analysis of visual evoked potential test	baseline and 6 months

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune,, Maharashtra, India