Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)

This study has been completed.

Sponsor:

Collaborators:

Cambridge University Hospitals NHS Foundation Trust

Medical Research Council

Information provided by (Responsible Party):

Peter Connick, University of Cambridge

ClinicalTrials.gov Identifier:

NCT00395200

First received: November 1, 2006

Last updated: October 22, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 2006

Last Updated Date

October 22, 2011

Start Date ^ICMJE

July 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Adverse events

Change History

Complete list of historical versions of study NCT00395200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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
Multiple Sclerosis Functional Composite Score
Expanded Kurtzke Disability Status Score

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)

Official Title ^ICMJE

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

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: MSC Treatment

Intervention: Procedure: MSC Treatment

Publications *

Connick P, Kolappan M, Patani R, Scott MA, Crawley C, He XL, Richardson K, Barber K, Webber DJ, Wheeler-Kingshott CA, Tozer DJ, Samson RS, Thomas DL, Du MQ, Luan SL, Michell AW, Altmann DR, Thompson AJ, Miller DH, Compston A, Chandran S. The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments. Trials. 2011 Mar 2;12:62.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00395200

Other Study ID Numbers ^ICMJE

MRCRG44871, REC Reference: 07/Q0108/104

Has Data Monitoring Committee

Yes

Responsible Party

Peter Connick, University of Cambridge

Study Sponsor ^ICMJE

University of Cambridge

Collaborators ^ICMJE

Cambridge University Hospitals NHS Foundation Trust
Medical Research Council

Investigators ^ICMJE

Principal Investigator:

Siddharthan Chandran, MBChB, PhD

University of Cambridge

Information Provided By

University of Cambridge

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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