Multiple Sclerosis MedDRA version: 16.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: XCEL-MC-ALPHA
Product Code: XCEL-MC-ALPHA
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Autologous adult mesenchymal stem cells from bone marrow expanded and cryopre
Sponsors
Banc de Sang i Teixits
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety and tolerability;Timepoint(s) of evaluation of this end point: 4, 12, 24, 28, 36 and 48th weeks;Main Objective: 1 - To evaluate the safety and tolerability of XCEL-MC-ALPHA by: a. Overall incidence of adverse events by treatment b. Incidence of adverse events by organ system preferred term, by treatment. c. Severity of adverse events per treatment. d. Intensity of adverse events per treatment. e. Causation by treatment.;Secondary Objective: Assess the effectiveness of XCEL-MC-ALPHA determined by the cumulative number of lesions that enhance with gadolinium T1 in sequence magnetic resonance in both treatment periods, in the group initially assigned to placebo and the group initially assigned to XCEL-MC-ALPHA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Lesions that enhance with gadolinium T1 in sequence magnetic resonance;Timepoint(s) of evaluation of this end point: 4, 12, 24, 28, 36 and 48th weeks | — |
Countries
Spain
Contacts
Public ContactRuth Coll
Banc de Sang i Teixits
Outcome results
None listed