Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)

Multiple Sclerosis Clinical Trial

— MSCIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395200
• Other study ID #: MRCRG44871
• Secondary ID: REC Reference: 0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2006
• Last updated: October 22, 2011
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• MSC Treatment
Intravenous administration of up to 2x10^6 autologous MSCs per kg

Locations

Country	Name	City	State
United Kingdom	University of Cambridge Dept of Clinical Neurosciences	Cambridge	Cambridgeshire
United Kingdom	University College London Institute of Neurology	London

Sponsors (3)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS Foundation Trust, Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		0,1,2,3,4,12 and 52 weeks post treatment	Yes
Secondary	Visual function (acuity and colour)		12 and 52 weeks post treatment	No
Secondary	Visual evoked potential latency		12 and 52 weeks post treatment	No
Secondary	Optic nerve Magnetisation Transfer Ratio		12 and 52 weeks post treatment	No
Secondary	Retinal nerve fibre layer thickness (by optical coherence tomography)		12 and 52 weeks post treatment	No
Secondary	Brain lesion Magnetisation Transfer Ratio		12 and 52 weeks post treatment	No
Secondary	MRI brain T1 hypointensity load		12 and 52 weeks post treatment	No
Secondary	Multiple Sclerosis Functional Composite Score		12 and 52 weeks post treatment	No
Secondary	Expanded Kurtzke Disability Status Score		12 and 52 weeks post treatment	No

External Links

•   Study protocol and baseline characteristics of the cohort
•   UCL Institute of Neurology
•   University of Cambridge Dept. of Clinical Neurosciences