Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01883661
• Other study ID #: CSCC/BM/2013/MS/01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 12, 2013
• Last updated: September 16, 2014
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D.Ortho
• Phone: 918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune,	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analysis of patients symptoms	Improvement in patients symptoms	baseline and 6 months	Yes
Secondary	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	baseline and 6 months	Yes
Secondary	changes in clinical variables		baseline and 6 months	Yes
Secondary	Quality Of life questionnaire		baseline and 6 months	Yes
Secondary	changes in MRI scan report		baseline and 6 months	Yes
Secondary	changes in cerebrospinal fluid tests		baseline and 6 months	Yes
Secondary	Changes in analysis of visual evoked potential test		baseline and 6 months	Yes