Back to resultsMesenchymal Stem Cell Transplantation in MS (CMM-EM)
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
autologous mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
Inflammatory forms of MS
- Relapsing-remitting MS (RRMS) patients
- Secondary progressive MS (SPMS) patients with continued relapses
- Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
- Age 18-50 years
- Disease duration >= 2 and >= 10 years
- EDSS 3.0 - 6.5
Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
- Increase of >= 1 EDSS point (if baseline EDSS <= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression
- >= 1 moderate-severe relapses in past 18 months
- >= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
- >= 1 new T2 lesion
- For PPMS only, >= 1 Gadolinium enhancing lesions
- Has given informed consent to participate in the study.
Exclusion Criteria:
- SPMS without ongoing relapses
- PPMS without positive CSF or Gadolinium enhancing lesions
- <= 3 months since treatment with any immunosuppressive therapy
- <=1 month since last treatment with interferon-B or glatiramer acetate
- Corticosteroid treatment <= 30 days
- Relapse <= 60 days
- History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
- Any metallic or electronic device that precludes from undergoing MRI
- Pregnancy or lactation
- Current treatment with an investigational therapy
Sites / Locations
- Neurology Service, Hospital Clinic de barcelona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
autologous mesenchymal stem cell
Arm Description
A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months
Outcomes
Primary Outcome Measures
To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study
The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI
Secondary Outcome Measures
To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales
clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis
Full Information
NCT ID
NCT01228266
First Posted
October 25, 2010
Last Updated
February 12, 2014
Sponsor
Albert Saiz
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT01228266
Brief Title
Mesenchymal Stem Cell Transplantation in MS
Acronym
CMM-EM
Official Title
Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Ended the recruitment in June 2012 for low enrollement accrual
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Albert Saiz
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous mesenchymal stem cell
Arm Type
Experimental
Arm Description
A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months
Intervention Type
Biological
Intervention Name(s)
autologous mesenchymal stem cells
Intervention Description
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
Primary Outcome Measure Information:
Title
To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study
Description
The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales
Description
clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inflammatory forms of MS
Relapsing-remitting MS (RRMS) patients
Secondary progressive MS (SPMS) patients with continued relapses
Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
Age 18-50 years
Disease duration >= 2 and >= 10 years
EDSS 3.0 - 6.5
Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
Increase of >= 1 EDSS point (if baseline EDSS <= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression
>= 1 moderate-severe relapses in past 18 months
>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
>= 1 new T2 lesion
For PPMS only, >= 1 Gadolinium enhancing lesions
Has given informed consent to participate in the study.
Exclusion Criteria:
SPMS without ongoing relapses
PPMS without positive CSF or Gadolinium enhancing lesions
<= 3 months since treatment with any immunosuppressive therapy
<=1 month since last treatment with interferon-B or glatiramer acetate
Corticosteroid treatment <= 30 days
Relapse <= 60 days
History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
Any metallic or electronic device that precludes from undergoing MRI
Pregnancy or lactation
Current treatment with an investigational therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Saiz, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology Service, Hospital Clinic de barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25436769
Citation
Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.
Results Reference
derived
Learn more about this trial
Mesenchymal Stem Cell Transplantation in MS
We'll reach out to this number within 24 hrs