Autologous Mesenchymal Stromal Cells for Multiple Sclerosis

• Status: Completed
• Trial end date: 2018-11-15
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.

Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6, the treatment will be crossed to receive the other product. The objective is to assess the safety of a single infusion BM-MSC, and to explore its efficacy in these patients.

Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banc de Sang i Teixits
• Collaborator: Vall d'Hebron Research Institute (VHIR)

Criteria

Inclusion Criteria:

• Patients between 18 and 60 years of age

• Patients with MS

• Relapsing-remitting or secondary progressive MS

• Patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs

• Expanded Disability Status Scale (EDDS) score <6.5

• Nine T2 lesions at least

• Active multiple sclerosis as defined either by 1 outbreak in the last year or at least one Gadolinium-enhancing lesion in the last 6 months

• Signed informed consent form

Exclusion Criteria:

• Interferon beta or glatiramer acetate 3 months prior the screening

• Natalizumab or fingolimod in the 6 months prior the screening

• Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time

• Has received an experimental treatment within 3 months prior the screening

• MS outbreak within the 4 weeks prior the randomization

• Serum creatinine> 2.0 mg/dl

• Infectious disease active or uncontrolled

• Fertile patients who are not using a suitable method of contraception

• Pregnant or lactating woman

• Immunodeficiency

• Positive serology to HIV, Hepatitis B, Hepatitis C or syphilis