Multiple sclerosis MedDRA version: 18.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Mesenchymal stem/stromal cells
Product Name: Mesenchymal stem cells (MSCs)
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for injec
Sponsors
Prof. Per Soelberg Sørensen
Eligibility
Sex/Gender
All
Inclusion 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) 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
Exclusion criteria
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of intra-venously applied autologous MSCs on cerebral inflammation in multiple sclerosis patients;Secondary Objective: To assess secondary endpoints as stated elsewhere;Primary end point(s): Number of Gadolinium positive lesions and / or newly demonstrated or increased T2 lesions (combined unique activity) over a period of 24 weeks after administration of MSCs compared with the control period (24 weeks).;Timepoint(s) of evaluation of this end point: 24 weeks after MSCs (or placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Comparison at 48 weeks between early versus late administration of MSCs by: a. Change in CUA (combined unique MRI activity), ie. new or enlarged T2 lesions or Gd positive lesion over a period of 48 weeks after administration of mesenchymal stem cells in the MSC group versus the control group b. Change in EDSS or functional systems c. Number of relapses over a period of 24 weeks after administration of MSCs in the MSC group versus the control group d. Disease-free patients (no relapse, progression or MRI activity) over a period of 24 weeks after administration of MSCs in the MSC group versus the control group 2. Time to first documented relapse over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo (infusion). A relapse is defined as development of new or worsening neurological symptoms and outcome in the absence of fever which lasts more than 48 hours. One documented relapse to be measured, corresponding to an increase of at least 1 point in either pyramidal, cerebellar, brain stem, sensory or visual function system or to an increase of at least ½ point on EDSS. A non-documented attack is one that does not meet the criteria for a confirmed relapse. 3. Total number of relapses (documented and undocumented) over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo. 4. The number of attack-free patients over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo. 5. Change in brain volume (SIENA atrophy measurements) over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo. 6. The number of new and enlarged T2-weighted lesions over a period of 24 weeks after administration of MSCs versus a period of 24 weeks after administration of placebo. 7. Volume Change of T2-weighted lesions over a period of 24 weeks after | — |
Countries
Denmark
Contacts
Public ContactCell Therapy Unit, The Blood Bank,
Dr. Roberto S. Oliveri
Outcome results
None listed