Bone marrow cell treatment as treatment of multiple sclerosis

• Conditions: Multiple Sclerosis; MedDRA version: 16.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000734-19-ES
• Lead Sponsor: Banc de Sang i Teixits

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-10
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

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

Inclusion Criteria

Patients with MS (McDonald 2010)
Clinical course of patients with relapsing-remitting MS or secondary progressive (Lublin and Reingold 1996)
Age between 18 and 60
Patients in whom is not indicated or are not in a position to begin treatment with drugs that modify disease available for MS, after the researcher has been informed of their benefits and potential adverse events, or who do not respond adequately to standard therapy or can not tolerate
EDSS < o = 6.5
At least nine T2 lesions
Active MS, defined by: At least one outbreak in the last year or At least one Gd-enhancing lesion in the last 6 months
Have signed the informed consent for participation in the stud
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 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients pre-treated with:
- Interferon beta or glatiramer acetate 3 months prior to screening
- Natalizumab or fingolimod in the 6 months prior to screening
- Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time
- Experimental treatment within 3 months prior to screening
MS attack in the 4 weeks prior to randomization
Serum creatinine> 2.0 mg / dl. If serum creatinine is> 1.2 mg / dl, measure glomerular filtration rate. Patients were excluded if the filtrate is <60 ml/minuto/1, 73 m2
Infectious disease active or uncontrolled
Fertile patients who are not using a suitable method of contraception (at the discretion of the investigator). If the patient is postmenopausal or sterile must be documented in the medical record.

Study & Design

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