NCT00395200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

2.4 years

First QC Date

November 1, 2006

Last Update Submit

October 22, 2011

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisSafetyTherapeuticsMesenchymal Stem CellsMultipotent Mesenchymal Stromal CellsOptic Neuritis

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    0,1,2,3,4,12 and 52 weeks post treatment

Secondary Outcomes (8)

  • Visual function (acuity and colour)

    12 and 52 weeks post treatment

  • Visual evoked potential latency

    12 and 52 weeks post treatment

  • Optic nerve Magnetisation Transfer Ratio

    12 and 52 weeks post treatment

  • Retinal nerve fibre layer thickness (by optical coherence tomography)

    12 and 52 weeks post treatment

  • Brain lesion Magnetisation Transfer Ratio

    12 and 52 weeks post treatment

  • +3 more secondary outcomes

Study Arms (1)

MSC Treatment

EXPERIMENTAL
Procedure: MSC Treatment

Interventions

MSC TreatmentPROCEDURE

Intravenous administration of up to 2x10\^6 autologous MSCs per kg

Also known as: Mesenchymal Stem Cells, Multipotent Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells
MSC Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cambridge Dept of Clinical Neurosciences

Cambridge, Cambridgeshire, CB2 0PY, United Kingdom

Location

University College London Institute of Neurology

London, London, WC1N 3BG, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 21366911BACKGROUND

  • Connick P, Kolappan M, Crawley C, Webber DJ, Patani R, Michell AW, Du MQ, Luan SL, Altmann DR, Thompson AJ, Compston A, Scott MA, Miller DH, Chandran S. Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study. Lancet Neurol. 2012 Feb;11(2):150-6. doi: 10.1016/S1474-4422(11)70305-2. Epub 2012 Jan 10.

    PMID: 22236384DERIVED

Related Links

MeSH Terms

Conditions

Multiple SclerosisOptic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Siddharthan Chandran, MBChB, PhD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

GB(2)