Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) - Full Text View

Sponsor:	University of Cambridge
Collaborators:	Cambridge University Hospitals NHS Foundation Trust Medical Research Council
Information provided by:	University of Cambridge
ClinicalTrials.gov Identifier:	NCT00395200

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Procedure: MSC Treatment	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by University of Cambridge:

Primary Outcome Measures:

Adverse events [ Time Frame: 0,1,2,3,4,12 and 52 weeks post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Visual function (acuity and colour) [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
Visual evoked potential latency [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
Optic nerve Magnetisation Transfer Ratio [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
Retinal nerve fibre layer thickness (by optical coherence tomography) [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
Brain lesion Magnetisation Transfer Ratio [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
MRI brain T1 hypointensity load [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
Multiple Sclerosis Functional Composite Score [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]
Expanded Kurtzke Disability Status Score [ Time Frame: 12 and 52 weeks post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MSC Treatment: Experimental	Procedure: MSC Treatment Intravenous administration of up to 2x10^6 autologous MSCs per kg

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)

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

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:

Primary
- Adverse events
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
Tertiary
- Multiple Sclerosis Functional Composite Score
- Expanded Kurtzke Disability Status Score

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395200

Locations

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

Sponsors and Collaborators

University of Cambridge

Cambridge University Hospitals NHS Foundation Trust

Medical Research Council

Investigators

Principal Investigator:

Siddharthan Chandran, MBChB, PhD

University of Cambridge

More Information

Additional Information:

University of Cambridge Dept. of Clinical Neurosciences This link exits the ClinicalTrials.gov site

UCL Institute of Neurology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Cambridge ( Siddharthan Chandran )
Study ID Numbers:	MRCRG44871, REC Reference: 07/Q0108/104
Study First Received:	November 1, 2006
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00395200 History of Changes
Health Authority:	United Kingdom: National Health Service; United Kingdom: Research Ethics Committee

Keywords provided by University of Cambridge:

Multiple Sclerosis
Safety
Therapeutics

Mesenchymal Stem Cells
Multipotent Mesenchymal Stromal Cells
Optic Neuritis

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009