Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395200
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : October 25, 2011
Sponsor:
Collaborators:
Cambridge University Hospitals NHS Foundation Trust
Medical Research Council
Information provided by (Responsible Party):
Peter Connick, University of Cambridge

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: MSC Treatment Phase 1 Phase 2

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Adverse events [ Time Frame: 0,1,2,3,4,12 and 52 weeks post treatment ]

Secondary Outcome Measures :
  1. Visual function (acuity and colour) [ Time Frame: 12 and 52 weeks post treatment ]
  2. Visual evoked potential latency [ Time Frame: 12 and 52 weeks post treatment ]
  3. Optic nerve Magnetisation Transfer Ratio [ Time Frame: 12 and 52 weeks post treatment ]
  4. Retinal nerve fibre layer thickness (by optical coherence tomography) [ Time Frame: 12 and 52 weeks post treatment ]
  5. Brain lesion Magnetisation Transfer Ratio [ Time Frame: 12 and 52 weeks post treatment ]
  6. MRI brain T1 hypointensity load [ Time Frame: 12 and 52 weeks post treatment ]
  7. Multiple Sclerosis Functional Composite Score [ Time Frame: 12 and 52 weeks post treatment ]
  8. Expanded Kurtzke Disability Status Score [ Time Frame: 12 and 52 weeks post treatment ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395200


Locations
Layout table for location information
United Kingdom
University of Cambridge Dept of Clinical Neurosciences
Cambridge, Cambridgeshire, United Kingdom, CB2 0PY
University College London Institute of Neurology
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Medical Research Council
Investigators
Layout table for investigator information
Principal Investigator: Siddharthan Chandran, MBChB, PhD University of Cambridge
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Peter Connick, Research Associate, University of Cambridge
ClinicalTrials.gov Identifier: NCT00395200    
Other Study ID Numbers: MRCRG44871
REC Reference: 07/Q0108/104
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011
Keywords provided by Peter Connick, University of Cambridge:
Multiple Sclerosis
Safety
Therapeutics
 Mesenchymal Stem Cells
Multipotent Mesenchymal Stromal Cells
Optic Neuritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases