Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395200
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2006-11-01
Brief Title:
Mesenchymal Stem Cells in Multiple Sclerosis MSCIMS
Sponsor:
University of Cambridge
Organization:
University of Cambridge
Study Overview
Official Title:
Autologous Adult Human Mesenchymal Stem Cells a Neuroprotective Therapy for Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSCIMS
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 IIIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis
Mesenchymal Stem Cells in Multiple Sclerosis MSCIMS is a phase IIIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis
Detailed Description:
Disease under investigation Multiple Sclerosis
Phase IIIA
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 2000000 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 20 - 65 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 2000000 cellskg 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 2000000 cellskg 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
Phase IIIA
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 2000000 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 20 - 65 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 2000000 cellskg 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 2000000 cellskg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REC Reference 07Q0108104 | None | None | None |