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

NCT02587806 | Unknown Phase 1 DMC

• 1 other identifier: PRT/NOVO/2015/002
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

RRMS

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with clinical improvement in EDSS score compared to baseline

  Clinical improvement is defined as decrease in Expanded Disability Status Scale (EDSS) score greater than 0.5 from baseline.

  Up to 12 months

• Proportion of patients with adverse events

  up to 12 months

Secondary Outcomes (9)

• Proportion of patients with a change in either gadolinium enhancing or new T2-weighted lesions on brain MRI

  12 months

• Proportion of patients with reduction in T2 lesion volume on brain MRI

  12 months

• Proportion of patients with reduction in brain volume on MRI

  12 months

• Proportion of patients with clinical improvement in EDSS score compared to baseline

  3 months and 6 months

• Proportion of patients with clinical improvement in MSIS score compared to baseline

  3 months, 6 months and 12 months

Study Arms (1)

Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC)

EXPERIMENTAL

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; Other: Liberation therapy

Interventions

Autologous Bone Marrow-Derived Mononuclear Stem Cells BIOLOGICAL

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)

Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC)

Liberation therapy OTHER

Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Cellular Medicine Institute LLP: lead

Study Sites (2)

Inamdar Multispecialty Hospital

Pune, Maharashtra, 411040, India

RECRUITING

Novo Cellular Medicine Institute

San Fernando, Trinidad, Trinidad and Tobago

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr. Bill Brashier, M.D.

  Novo Cellular Medicine Institute LLP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Senthil Thyagarajan, PhD

CONTACT

+91 8554982236; drsenthil@novomedinstitute.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

TR (1); IN (1)