Mesenchymal stem cells therapy for patients with multiple sclerosis

• Conditions: multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-000137-78-AT
• Lead Sponsor: SALK - Gemeinnützige Salzburger Landeskliniken Betriebsges. m.b.H., Christian-Doppler-Klinik, UK für Neurologie der PM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-17
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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 (Betainterferon, Glatirameracetate, 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 or new T2 lesion at MRI performed within the last 12 months compared to a previous 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 (betainterferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by both:
i. an increase of =1.0 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 following features:
i. an increase of =1.0 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 GEL at MRI performed within the last 12 months
iii. positive cerebrospinal fluid (CSF), oligoclonal banding
2. Age 18 to 50 years
3. Disease duration 2 to 10 years (included)
4. EDSS 3.0 to 6.5
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 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

These criteria are used to exclude MS patients with medical problems that would significantly increase their risk of serious morbidity or mortality from MSCT or any other facet of this protocol:
1. RRMS not fulfilling inclusion criteria
2. SPMS not fulfilling inclusion criteria
3. PPMS not fulfilling inclusion criteria
4. Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or C, syphilis
5. Any chronic or acute disease or Known allergy to any substances related to study treatment that could be non compatible with the trial protocol as per clinician’s judgement
6. Treatment with any immunosuppressive therapy, including Natalizumab and Fingolimod, within the 3 months prior to randomization
7. Treatment with Interferon-beta or glatiramer acetate within the 30 days prior to randomization
8. Treatment with corticosteroids within the 30 days prior to randomization
9. Relapse occurred during the 60 days prior to randomization
10. Previous history of malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than 1 year
11. Severely limited life expectancy by another co-morbid illness
12. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
13. Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
14. eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
15. Inability to give written informed consent

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 safety of IV therapy with autologous MSCs in multiple sclerosis patients;Secondary Objective: 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).;Primary end point(s): incidence and severity of adverse events in MSCs treatment group compared to placebo group<br>Co-primary endpoint:<br> number of GEL counted over week 4, 12 and 24 compared between treatment groups;Timepoint(s) of evaluation of this end point: 24 weeks after MSCs treatment or placebo