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 个研究点开始时间: 2012年6月21日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•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)
•d.>=1 new T2 lesion
•6.Evidence for actual inflammatory aktivity, demonstrated by one of the following:
•a.>=1 moderate-severe attack within the last 18 months
•b.>=1 Gadolinium positive lesion (double or triple dose Gd)
•c.>=1 new T2 lesion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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
•11. Previously demonstrated renal insufficiency
•12. Any medical or psychiatric condition or other circumstance that affects the neurological assessment of the person and thereby affect the study's clarification
•13. Contraindication to MRI with gadolinium contrast (eg pacemakers, metal implants)

发起方

Prof. Per Soelberg Sørensen