NCT01883661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2.4 years

First QC Date

June 12, 2013

Last Update Submit

September 16, 2014

Conditions

Multiple Sclerosis

Keywords

stem cellMultiple SclerosisBMMNC

Outcome Measures

Primary Outcomes (1)

  • analysis of patients symptoms

    Improvement in patients symptoms

    baseline and 6 months

Secondary Outcomes (6)

  • changes in Expanded Kurtzke Disability Status Score scale

    baseline and 6 months

  • 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

  • +1 more secondary outcomes

Study Arms (1)

BMMNC

OTHER

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

Biological: BMMNC

Interventions

BMMNCBIOLOGICAL

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

BMMNC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • ANANT E BAGUL, MS ORTHO

    Chaitanya Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin P Jamadar, D.Ortho

CONTACT

918888788880sac2751982@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub Investigator

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 21, 2013

Study Start

June 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)