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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-8n8csf Effect of Mesenchymal stem cells in patients with decompensated cirrhosis


                                Date of registration:
                                
                                    08/26/2020                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    08/26/2020                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Bone marrow mesenchymal stem cells in acute-on-chronic liver failure grades 2 and 3: a phase I-II randomized clinical trial 

                                        

                                        
pt-br

                                        
Uso de células tronco mesenquimais em pacientes com acute-on-chronic liver failure


                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1254-7100
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Effect of Mesenchymal stem cells in patients with decompensated cirrhosis
    
                                                
    
                                                    
    pt-br
    
                                                    
    Efeito das células tronco em pacientes com cirrose descompensada

    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
    • 
                                                    92330718.0.0000.5327	
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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                                                    20180643
      
                                                    Issuing authority:
                                                    Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Hospital de Clínicas de Porto Alegre
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Hospital de Clínicas de Porto Alegre
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Fundo de Incentivo à Pesquisa e Eventos do Hospital de Clínicas de Porto Alegre
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Fibrosis and cirrhosis of liver
    
                                                
    
                                                
    pt-br
    
                                                
    Fibrose e cirrose hepáticas
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                                                                
    
                                                
    en
    
                                                
    
                                                    K00-K93
                                                    XI - Diseases of the digestive system
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    K00-K93
                                                    XI - Doenças do aparelho digestivo
                                                
    
                                                
                                            
     
    
                                    
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    Specific descriptors:
    
                                                                                
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Experimental group: 4 patients with grades 2 and 3 acute-on-chronic liver failure who will receive bone marrow-derived mesenchymal stem cells associated with standard medical treatment. Control group: 5 patients with grades 2 and 3 acute-on-chronic liver failure who will receive 0.9% saline solution associated with standard medical treatment
    
                                                
    
                                                
    pt-br
    
                                                
    Grupo experimental: 4 pacientes com acute-on-chronic liver failure de graus 2 e 3 que receberão células tronco mesenquimais derivadas da medula óssea associado ao tratamento médico padrão. Grupo controle: 5 pacientes com acute-on-chronic liver failure de graus 2 e 3 que receberão solução de salina a 0,9% associado ao tratamento médico padrão
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        A11.329.830.500
                                                        Mesenchymal Stem Cells
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        A11.329.830.500
                                                        Células-Tronco Mesenquimais
                                                    
    
                                                    
    
                                                    
    es
    
                                                    
    
                                                        A11.329.830.500
                                                        Células Madre Mesenquimatosas
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Data analysis completed
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        09/01/2018                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                9
                                                -
                                                18 Y
                                                70 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    fulfilling ACLF diagnostic criteria and ACLF grade 2 or 3
    
                                                
    
                                                
    pt-br
    
                                                
    Preencher critérios diagnósticos de ACLF e ter graus 2 ou 3
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    patient’s or family member’s refusal; (b) hepatocellular carcinoma (HCC); (c) formal contraindicationfor liver transplantation (e.g. advanced heart or pulmonary disease); (d) pregnancy and lactation; (e) previous liver transplantation; (f) HIV co-infection; (g) ACLF grade 1; (h) patients admitted for elective procedures; (i) renal chronic disease requiring dialysis.
    
                                                
    
                                                
    pt-br
    
                                                
    Recusa do paciente ou familiar; Carcinoma hepatocelular; Contraindicação ao transplante hepático; gravidez ou lactação; co-infecção pelo HIV; ACLF grau 1; pacientes admitidos para procedimentos eletivos; doença renal crônica com necessidade de diálise
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                
                                                Treatment
                                                Parallel
                                                2
                                                Double-blind
                                                Randomized-controlled
                                                1-2
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        Evaluate mortality in the period of 28 and 90 days, verified by means of the Kaplain-Meier curves, from the observation of a variation post-intervention
                                                    
    
                                                    
    
                                                    
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                                                        Avaliar a mortalidade no período de 28 e 90 dias, verificado por meio das curvas de Kaplain-Meier, a partir da constatação de uma variação pós-intervenção



                                                    
    
                                                    
    
                                                    
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                                                        Assess adverse effects, verified through clinical changes and vital signs, based on the observation of a post-intervention variation
                                                    
    
                                                    
    
                                                    
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                                                        Avaliar os efeitos adversos, verificado por meio das alterações clínicas e de sinais vitais, a partir da constatação de uma variação pós-intervenção
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
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                                                    Evaluate liver function patterns (prothrombin time, bilirubins and albumin) and inflammatory markers (total leukocytes and C-reactive protein) in the pre- and post-infusions of mesenchymal stem cells compared to placebo
                                                
    
                                                
    
                                                
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                                                    Avaliar os padrões de função hepática (tempo de protrombina, bilirrubinas e albumina) e marcadores inflamatórios (leucócitos totais e proteína C reativa) no período pré e pós-infusões de células tronco mesenquimais comparativamente ao placebo
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Fernando Comunello Schacher
                                                
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                                                            Address:
                                                            Rua João Beruti, 160/303
                                                        
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                                                            City: 
                                                            Porto Alegre / Brazil
                                                        
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                                                            Zip code:
                                                            91330-370
                                                        
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                                                    Phone:
                                                    (51) 981958310
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Hospital de Clínicas de Porto Alegre
                                                
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    • 
                                                    Full name:
                                                    Fernando Comunello Schacher
                                                
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      • 
                                                            Address:
                                                            Rua João Berutti, 160/303
                                                        
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                                                            City: 
                                                            Porto Alegre / Brazil
                                                        
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      • 
                                                            Zip code:
                                                            91330-370
                                                        
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                                                    Phone:
                                                    (55 51) 981958310
                                                
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                                                    Email:
                                                    
                                                
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    • 
                                                    Affiliation:
                                                    Hospital de Clínicas de Porto Alegre
                                                
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                                        Scientific contact

                                        
      
                                                                                            
    • 
                                                    Full name:
                                                    Fernando Comunello Schacher
                                                
      • 
                                                
    • 
                                                    
        
                                                        
      • 
                                                            Address:
                                                            Rua João Berutti, 160/303
                                                        
        • 
                                                        
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                                                            City:
                                                            Porto Alegre / Brazil
                                                        
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      • 
                                                            Zip code:
                                                            91330-370
                                                        
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    • 
                                                    Phone:
                                                    (55 51) 981958310
                                                
      • 
                                                
    • 
                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    Hospital de Clínicas de Porto Alegre
                                                
      • 
                                                                                            
    • 
                                                    Full name:
                                                    Fernando Comunello Schacher
                                                
      • 
                                                
    • 
                                                    
        
                                                        
      • 
                                                            Address:
                                                            Rua João Beruti, 160/303
                                                        
        • 
                                                        
      • 
                                                            City:
                                                            Porto Alegre / Brazil
                                                        
        • 
                                                        
      • 
                                                            Zip code:
                                                            91330-370
                                                        
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    • 
                                                    Phone:
                                                    (51) 981958310
                                                
      • 
                                                
    • 
                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    Hospital de Clínicas de Porto Alegre
                                                
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  • 
                                        Site contact

                                        
      
                                                                                            
    • 
                                                    Full name:
                                                    Fernando Comunello Schacher
                                                
      • 
                                                
    • 
                                                    
        
                                                        
      • 
                                                            Address:
                                                            Rua João Berutti, 160/303
                                                        
        • 
                                                        
      • 
                                                            City:
                                                            Porto Alegre / Brazil
                                                        
        • 
                                                        
      • 
                                                            Zip code:
                                                            91330-370
                                                        
        • 
                                                    
      
                                                
      • 
                                                
    • 
                                                    Phone:
                                                    (55 51) 981958310
                                                
      • 
                                                
    • 
                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    Hospital de Clínicas de Porto Alegre
                                                
      • 
                                                                                            
    • 
                                                    Full name:
                                                    Fernando Comunello Schacher
                                                
      • 
                                                
    • 
                                                    
        
                                                        
      • 
                                                            Address:
                                                            Rua João Beruti, 160/303
                                                        
        • 
                                                        
      • 
                                                            City:
                                                            Porto Alegre / Brazil
                                                        
        • 
                                                        
      • 
                                                            Zip code:
                                                            91330-370
                                                        
        • 
                                                    
      
                                                
      • 
                                                
    • 
                                                    Phone:
                                                    (51) 981958310
                                                
      • 
                                                
    • 
                                                    Email:
                                                    
                                                
      • 
                                                
    • 
                                                    Affiliation:
                                                    Hospital de Clínicas de Porto Alegre
                                                
      • 
                                                                                    
    
                                        
     
    
                                    
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


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