Trial record 6 of 18 for:    CCSVI

A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Novo Cellular Medicine Institute LLP
Sponsor:
Information provided by (Responsible Party):
Novo Cellular Medicine Institute LLP
ClinicalTrials.gov Identifier:
NCT02587806
First received: October 26, 2015
Last updated: October 27, 2015
Last verified: October 2015
  Purpose

STUDY OBJECTIVES:

Primary Objective: Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.

Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3 months, 6 months and 12 months after treatment based on the following: EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1) Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and gadolinium-enhanced magnetic resonance imaging (MRI).


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells
Other: Liberation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non-randomized, Phase I/II Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS

Resource links provided by NLM:


Further study details as provided by Novo Cellular Medicine Institute LLP:

Primary Outcome Measures:
  • Proportion of patients with clinical improvement in EDSS score compared to baseline [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Clinical improvement is defined as decrease in Expanded Disability Status Scale (EDSS) score greater than 0.5 from baseline.

  • Proportion of patients with adverse events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with a change in either gadolinium enhancing or new T2-weighted lesions on brain MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with reduction in T2 lesion volume on brain MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with reduction in brain volume on MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with clinical improvement in EDSS score compared to baseline [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients with clinical improvement in MSIS score compared to baseline [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with a change in mobility and leg function as measured by the 25 foot walking test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with a change in upper extremity function as measured by the Nine Hole Peg Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with a change in cognitive function as measured by the Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with reduced number of relapses or freedom from progression of disease [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: February 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC)
Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Biological: Autologous Bone Marrow-Derived Mononuclear Stem Cells
Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Other: Liberation therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females between age 18 and 60 years
  • Diagnosis of Relapsing Remitting Multiple Sclerosis made by a neurology expert/MS expert with lesions demonstrated on brain MRI that are consistent with MS
  • Duration of disease: >5 years
  • Having an EDSS (Kurtzke Expanded Disability Status Scale) score between 3.5 & 6
  • History of 2 or more relapses within last 2 years with increase in EDSS scale of > 0.5 sustained for > 4 weeks
  • Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments): the lack of response to these treatments will be determined/defined by history of 2 or more relapses within last 2 years with increase in EDSS scale of > 0.5 sustained for > 4 weeks
  • Must have proof of health insurance in country of residence

Exclusion Criteria:

  • Primary progressive, secondary progressive or progressive relapsing MS as defined by Lublin and Reingold, 1996. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing remitting subjects by the lack of clinically stable periods of clinical improvement.
  • Unable to perform Timed 25-Foot Walk, 9 Hole Peg Test (HPT) (with both upper extremities) and Paced Auditory Serial Addition Test (PASAT 3)
  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Life expectancy < 6 months due to concomitant illnesses
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Active infectious disease: For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
  • Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
  • Patients with unstable cardiac status (unstable angina, attack of myocardial infarction within last 6 months, uncontrolled high blood pressure, hypotension, cardiomyopathy)
  • Cerebrovascular accident within 6 months prior to study entry
  • Patients with poorly controlled diabetes mellitus
  • Patients with renal insufficiency (Creatinine> 2.5) or failure
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator is not suitable to participate.
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years
  • Unwilling and/or not able to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02587806

Contacts
Contact: Dr. Senthil Thyagarajan, PhD +91 8554982236 drsenthil@novomedinstitute.org

Locations
India
Inamdar Multispecialty Hospital Recruiting
Pune, Maharashtra, India, 411040
Contact: Dr. Malik Javeri, M.D.    +91 9766476793    india@novomedinstitute.org   
Sub-Investigator: Dr. Malik Javeri, M.D.         
Sub-Investigator: Dr. Anand Alurkar, M.D.         
Trinidad and Tobago
Novo Cellular Medicine Institute Recruiting
San Fernando, Trinidad, Trinidad and Tobago
Contact: Dr. Bill Brashier, M.D.    001868 770 9152    drbill@novomedinstitute.org   
Principal Investigator: Dr. Bill Brashier, M.D.         
Sub-Investigator: Dr. Purandath Lall, M.S.         
Sub-Investigator: Dr. Rupert Indar, M.S.         
Sponsors and Collaborators
Novo Cellular Medicine Institute LLP
Investigators
Principal Investigator: Dr. Bill Brashier, M.D. Novo Cellular Medicine Institute LLP
  More Information

Publications:

Responsible Party: Novo Cellular Medicine Institute LLP
ClinicalTrials.gov Identifier: NCT02587806     History of Changes
Other Study ID Numbers: PRT/NOVO/2015/002 
Study First Received: October 26, 2015
Last Updated: October 27, 2015
Health Authority: Trinidad and Tobago : Ministry of Health
India: Ministry of Health

Keywords provided by Novo Cellular Medicine Institute LLP:
RRMS

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2016