Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Cambridge Cambridge University Hospitals NHS Foundation Trust Medical Research Council |
---|---|
Information provided by: | University of Cambridge |
ClinicalTrials.gov Identifier: | NCT00395200 |
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 | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Procedure: MSC Treatment |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis |
Estimated Enrollment: | 10 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
MSC Treatment: Experimental |
Procedure: MSC Treatment
Intravenous administration of up to 2x10^6 autologous MSCs per kg
|
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)
Evidence of optic nerve damage by
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:
Primary
Secondary
Tertiary
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
University College London Institute of Neurology | |
London, United Kingdom, WC1N 3BG | |
United Kingdom, Cambridgeshire | |
University of Cambridge Dept of Clinical Neurosciences | |
Cambridge, Cambridgeshire, United Kingdom, CB2 0PY |
Principal Investigator: | Siddharthan Chandran, MBChB, PhD | University of Cambridge |
Responsible Party: | University of Cambridge ( Siddharthan Chandran ) |
Study ID Numbers: | MRCRG44871, REC Reference: 07/Q0108/104 |
Study First Received: | November 1, 2006 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00395200 History of Changes |
Health Authority: | United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
Multiple Sclerosis Safety Therapeutics |
Mesenchymal Stem Cells Multipotent Mesenchymal Stromal Cells Optic Neuritis |
Papillitis Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Sclerosis Autoimmune Diseases of the Nervous System Optic Neuritis Neuritis |
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |