Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) — MSCIMS  

Multiple Sclerosis Clinical Trial

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

Status Completed

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.

Clinical Trial 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 ;

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

• NCT number: NCT00395200
• Study type: Interventional
• Source: University of Cambridge
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2008
• Completion date: December 2010