UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure
21. juni 2016 oppdatert av: Lin Bingliang, Sun Yat-sen University
Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality.
Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients.
In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
261
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity < 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
- Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
- End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
Exclusion Criteria:
- Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
- Concomitant autoimmune disease;
- Superinfection with other hepatitis viruses;
- Important organ dysfunctions not due to liver disease or malignancies;
- Pregnancy and lactation;
- Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
- Bioartificial liver support therapy;
- Previous liver transplantation.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Group MSC-1
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks.
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Eksperimentell: Group MSC-2
Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks.
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Ingen inngripen: Group Control
Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
Tidsramme: 52 weeks
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52 weeks
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The survival time of patients after UC-MSC infusions.
Tidsramme: 52 weeks
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52 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
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1,2,3,4,8,12,24,36,52weeks
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The influence on levels of ALB(g/L) after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
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1,2,3,4,8,12,24,36,52weeks
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The influence on levels of TBil (umol/L) after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
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1,2,3,4,8,12,24,36,52weeks
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The influence on levels of INR after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
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1,2,3,4,8,12,24,36,52weeks
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The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
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1,2,3,4,8,12,24,36,52weeks
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The incidence of fatal complications after UC-MSC infusions.
Tidsramme: 52 weeks
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52 weeks
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Comparison of levels of NKG2A among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of NKG2D among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of NKP46 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of perforin among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of FasL among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Comparison of levels of gramzymeB among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
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2,4,8,12,24,36,52 weeks
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2016
Primær fullføring (Forventet)
1. juni 2017
Studiet fullført (Forventet)
1. juni 2018
Datoer for studieregistrering
Først innsendt
27. mai 2016
Først innsendt som oppfylte QC-kriteriene
21. juni 2016
Først lagt ut (Anslag)
24. juni 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. juni 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juni 2016
Sist bekreftet
1. juni 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UCBMSC
- LBingliang (Registeridentifikator: Bing-liang Lin)
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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