- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730547
Mesenchymal Stem Cells for Multiple Sclerosis
Phase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Lou Brundin, MD.Professor
- Phone Number: +46 +46 7074848505
- Email: lou.brundin@karolinska.se
Study Contact Backup
- Name: Ellen Iacobaeus, MD.PhD
- Phone Number: +46 +46 707433644
- Email: ellen.iacobaeus@karolinska.se
Study Locations
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Stockholm, Sweden, 171 76
- Karolinska Institute, Karolinska University Hospital Solna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosis of MS
a. Relapsing remitting MS (RRMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by one or more of the following: i. ≥1 clinically documented relapse in past 12 months ii. ≥2 clinically documented relapses in last 24 months iii. ≥1 GEL at MRI performed within the last 12 months
b. Secondary progressive MS (SPMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by both: i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the last 12 months ii. ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months.
c. Primary progressive MS (PPMS) patients with all the following features: i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥5.5), in the last twelve months ii. ≥ 1 GEL at MRI performed within the last 12 months iii. positive cerebrospinal fluid (CSF) (oligoclonal banding)
- Age 18 to 50 years
- Disease duration 2 to 10 years (included)
- EDSS 3.0 to 6.5
Exclusion Criteria:
- RRMS not fulfilling inclusion criteria
- SPMS not fulfilling inclusion criteria
- PPMS not fulfilling inclusion criteria
- Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C
- Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
- Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
- Treatment with corticosteroids within the 30 days prior to randomization
- Relapse occurred during the 60 days prior to randomization
- Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
- Severely limited life expectancy by another co-morbid illness
- History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
- Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
- eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
- Inability to give written informed consent in accordance with research ethics board guidelines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early treatment with mesenchymal stem cells
Patients receive a single intravenous dose of autologous bone marrow-derived MSCs followed by placebo at week 24.
Fommow up at week 48
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Active Comparator: Delayed treatment with mesenchymal stem cells
Patients receive placebo for 24 weeks followed by autologous MSCs at week 24, with a follow-up visit at week 48.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the safety of IV therapy with autologous Mesenchymal Stem Cells (MSCs) in MS patients.
Time Frame: 48 weeks
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The primary objective of the study is to assess the safety of IV therapy with autologous MSCs in MS.
Number of participants with adverse events will be documented at week 0,4,8,12,16,20,24,28,32,36,40,44,48 post treatment.
Co-primary objective of the study is to evaluate the activity of autologous MSCS in MS patients, in terms of reduction as compared to placebo in the total number of contrast-enhancing lesions (GEL) at MRI acquired on conventional 1,5 T MRI scans over 24 weeks.
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To gather preliminary information of the efficacy of the experimental treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and disability progression).
Time Frame: 48 weeks
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48 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSC-MS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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