Clinical trial NCT01883661: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: stem cell
Multiple Sclerosis
BMMNC
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: analysis of patients symptoms
timeFrame: baseline and 6 months
Secondary outcomes:
measure: changes in Expanded Kurtzke Disability Status Score scale
timeFrame: baseline and 6 months
measure: changes in clinical variables
timeFrame: baseline and 6 months
measure: Quality Of life questionnaire
timeFrame: baseline and 6 months
measure: changes in MRI scan report
timeFrame: baseline and 6 months
measure: changes in cerebrospinal fluid tests
timeFrame: baseline and 6 months
measure: Changes in analysis of visual evoked potential test
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Pune,
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: Chaitanya Hospital
name: ANANT E BAGUL, MS ORTHO
role: PRINCIPAL_INVESTIGATOR
References: