Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) (MSCIMS)

October 22, 2011 updated by: Peter Connick, University of Cambridge

Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis

Hypothesis: Intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis.

Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Disease under investigation: Multiple Sclerosis

Phase: I/IIA

Number of patients: 10

Design: 18 month cross over, single treatment at 6 months

Intervention: Administration of bone marrow-derived autologous mesenchymal stem cells

Route of administration: Intravenous

Dose: Up to 2,000,000 Mesenchymal Stem Cells per kilogram

Source of patients: Referrals accepted from Neurologists in East Anglia and North London, UK

Referral Criteria: (all 3 required)

  1. Clinically definite multiple sclerosis
  2. Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive)

  3. Evidence of optic nerve damage by

    • history of optic neuritis, or
    • relative afferent pupillary defect, or
    • optic atrophy on fundoscopy, or
    • abnormal visual evoked potential from either or both eyes suggestive of demyelination

Primary Objective: Establish the safety of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months by monitoring adverse reactions.

Secondary Objectives: Explore the efficacy of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months on visual function by clinical, neurophysiological, and imaging assessments.

Outcome Measures:

  1. Primary

    • Adverse events

  2. Secondary

    • Visual function (acuity and colour)
    • Visual evoked potential latency
    • Optic nerve Magnetisation Transfer Ratio
    • Retinal nerve fibre layer thickness (by optical coherence tomography)
    • Brain lesion Magnetisation Transfer Ratio
    • MRI brain T1 hypointensity load
    • T cell response suppression

  3. Tertiary

    • Multiple Sclerosis Functional Composite Score
    • Expanded Kurtzke Disability Status Score

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • University College London Institute of Neurology
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0PY
        • University of Cambridge Dept of Clinical Neurosciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically definite multiple sclerosis
  • Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive)
  • Evidence of optic nerve damage by:
  • history of optic neuritis, or
  • relative afferent pupillary defect, or
  • optic atrophy on fundoscopy, or
  • abnormal visual evoked potential from either or both eyes suggestive of demyelination
  • Prolonged visual evoked potential P100 latency with preserved waveform
  • T2 lesion on MRI optic nerve
  • Retinal nerve fibre layer thickness on optical coherence tomography > 40 microns

Exclusion Criteria:

  • Age < 18 years
  • Age > 65 years
  • Patient lacks capacity to give informed consent
  • Presence of a severe bleeding disorder
  • Planning a pregnancy during the trial period
  • Current MS disease modifying therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSC Treatment
Procedure: MSC Treatment
Intravenous administration of up to 2x10^6 autologous MSCs per kg
Other Names:
  • Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stromal Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 0,1,2,3,4,12 and 52 weeks post treatment
0,1,2,3,4,12 and 52 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual function (acuity and colour)
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
Visual evoked potential latency
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
Optic nerve Magnetisation Transfer Ratio
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
Retinal nerve fibre layer thickness (by optical coherence tomography)
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
Brain lesion Magnetisation Transfer Ratio
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
MRI brain T1 hypointensity load
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
Multiple Sclerosis Functional Composite Score
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment
Expanded Kurtzke Disability Status Score
Time Frame: 12 and 52 weeks post treatment
12 and 52 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

Cambridge University Hospitals NHS Foundation Trust
Medical Research Council

Investigators

  • Principal Investigator: Siddharthan Chandran, MBChB, PhD, University of Cambridge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 1, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 22, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCRG44871
  • REC Reference: 07/Q0108/104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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