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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

November 1, 2006
October 22, 2011
July 2008
December 2010   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: 0,1,2,3,4,12 and 52 weeks post treatment ] [ Designated as safety issue: Yes ]
Adverse events
Complete list of historical versions of study NCT00395200 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)
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.

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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
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
Experimental: MSC Treatment
Intervention: Procedure: MSC Treatment
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. doi: 10.1186/1745-6215-12-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00395200
MRCRG44871, REC Reference: 07/Q0108/104
Yes
Peter Connick, University of Cambridge
University of Cambridge
  • Cambridge University Hospitals NHS Foundation Trust
  • Medical Research Council
Principal Investigator: Siddharthan Chandran, MBChB, PhD University of Cambridge
University of Cambridge
October 2011

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