EUCTR2012-000518-13-DK
Active, not recruiting
Phase 1
Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study - COMSCIMS
Prof. Per Soelberg Sørensen0 sitesJune 21, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple sclerosis
- Sponsor
- Prof. Per Soelberg Sørensen
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Inflammatory form of multiple sclerosis (MS)
- •a. Relapsing\-remitting MS (RRMS)
- •b. Secondary progressive MS (SPMS) with attacks within the last year
- •2\. Age 18\-50 yr
- •3\. Affected by MS 2 to 10 years
- •4\.Expanded disability status scale (EDSS) 3\.0\-6\.5
- •5\.Progression, attacks and/or progression on MRI after \>\= 1 yr on disease modifying treatment demonstrated by at least one of the following criteria:
- •a.Increase \>\=1 EDSS point, if baseline EDSS \>\= 5\.0 or 0\.5 EDSS point, if baseline EDSS \>\=5\.5, or quantifiable objective evidence for similar progression
- •b.\>\=1 moderate\-severe attack within the last 18 months
- •c.\>\=1 Gadolinium positive lesion (double or triple dose Gd)
Exclusion Criteria
- •1\. Secondary progressive MS without relapses
- •2\. Primary progressive MS
- •3\. \<\= 3 months since treatment with immunosuppressive agents
- •4\. \<\= 1 month since modification of therapy with interferon beta or glatiramer acetate
- •5\. Glucocorticosteroid therapy within the last 30 days
- •6\. Attack within past 60 days
- •7\. Pregnancy (detected by urinary hCG in fertile women) or lactation
- •8\. Uncertain contraception. Acceptable methods of contraception are: sexual inactivity, surgical sterilization, spiral, p\-pill or similar p\-patch transdermal contraceptive pill or implant or double barrier method (condom or diaphragm with spermicide cream)
- •9\. Congestive heart failure (NYHA III / IV), cardiomyopathy, heart rhythm disorder requiring treatment, unstable or severe heart disease (CCS III or IV), severe hypertension (systolic greater than 180, diastolic greater than 110\)
- •10\. Previously demonstrated hematologic disease
Outcomes
Primary Outcomes
Not specified
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