Own mesenchymal stem cells for multiple sclerosis patients

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 18.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000518-13-DK
• Lead Sponsor: Prof. Per Soelberg Sørensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-21
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)