Multiple SclerosisPhase 1/2MSCIMSNCT00395200
Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)
A Phase 1/2 study testing MSC Treatment in people with Multiple Sclerosis, run by University of Cambridge at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MSC Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2008to Dec 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Cambridge Dept of Clinical Neurosciences
Cambridge, Cambridgeshire, CB2 0PY
University College London Institute of Neurology
London, London, WC1N 3BG
About this study
Official title: Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis
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.
Read the detailed 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)
- 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
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
- Adverse events
- 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
- Tertiary
- Multiple Sclerosis Functional Composite Score
- Expanded Kurtzke Disability Status Score
- Conditions
- Multiple Sclerosis
- Being tested
- MSC Treatment
- Keywords
- Multiple Sclerosis, Safety, Therapeutics, Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells, Optic Neuritis
- Medical subject headings
- Multiple Sclerosis, Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC TreatmentProcedure or surgery
Also called Mesenchymal Stem Cells, Multipotent Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells
Intravenous administration of up to 2x10^6 autologous MSCs per kg
| Study group | Role | What they receive |
|---|---|---|
| MSC Treatment | Experimental | Not described Receives: Procedure: MSC Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 0,1,2,3,4,12 and 52 weeks post treatment
Secondary outcomes (8)
Visual function (acuity and colour)
Measured: 12 and 52 weeks post treatment
Visual evoked potential latency
Measured: 12 and 52 weeks post treatment
Optic nerve Magnetisation Transfer Ratio
Measured: 12 and 52 weeks post treatment
Retinal nerve fibre layer thickness (by optical coherence tomography)
Measured: 12 and 52 weeks post treatment
Brain lesion Magnetisation Transfer Ratio
Measured: 12 and 52 weeks post treatment
MRI brain T1 hypointensity load
Measured: 12 and 52 weeks post treatment
Multiple Sclerosis Functional Composite Score
Measured: 12 and 52 weeks post treatment
Expanded Kurtzke Disability Status Score
Measured: 12 and 52 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Medical Research Council
- Responsible party
- Principal investigator, Peter Connick, University of Cambridge
- Investigators
- Siddharthan Chandran, MBChB, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395200
- Sponsor's protocol ID
- MRCRG44871
- Other IDs
- REC Reference: 07/Q0108/104
- Acronym
- MSCIMS
- Status last verified
- Oct 2011
- First submitted
- 1 Nov 2006
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21366911Connick 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.
PubMed 22236384
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Adult Human Mesenchymal Stem Cells: a Neuroprotective Therapy for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00395200
- Acronym / sponsor ID
- MSCIMS / MRCRG44871
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Safety, Therapeutics, Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells, Optic Neuritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Medical Research Council
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
- 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
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
- Adverse events
- 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
- Tertiary
- Multiple Sclerosis Functional Composite Score
- Expanded Kurtzke Disability Status Score
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC Treatment | Experimental | Procedure: MSC Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC TreatmentAlso: Mesenchymal Stem Cells, Multipotent Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal CellsIntravenous administration of up to 2x10^6 autologous MSCs per kg | Procedure or surgery | MSC Treatment |
Primary outcome
Adverse events
Time frame: 0,1,2,3,4,12 and 52 weeks post treatment
8 secondary outcomes
Visual function (acuity and colour)
Time frame: 12 and 52 weeks post treatment
Visual evoked potential latency
Time frame: 12 and 52 weeks post treatment
Optic nerve Magnetisation Transfer Ratio
Time frame: 12 and 52 weeks post treatment
Retinal nerve fibre layer thickness (by optical coherence tomography)
Time frame: 12 and 52 weeks post treatment
Brain lesion Magnetisation Transfer Ratio
Time frame: 12 and 52 weeks post treatment
MRI brain T1 hypointensity load
Time frame: 12 and 52 weeks post treatment
Multiple Sclerosis Functional Composite Score
Time frame: 12 and 52 weeks post treatment
Expanded Kurtzke Disability Status Score
Time frame: 12 and 52 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
- Background: PubMed 21366911Connick 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.
- Derived from this study: PubMed 22236384Connick 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.
- University of Cambridge Dept. of Clinical NeurosciencesLink provided by the sponsor.
- UCL Institute of NeurologyLink provided by the sponsor.
- Study protocol and baseline characteristics of the cohortLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siddharthan Chandran, MBChB, PhD principal investigator
University of Cambridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC Treatment in people with Multiple Sclerosis, run by University of Cambridge at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 0,1,2,3,4,12 and 52 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395200, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2011.