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UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure

21. juni 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

261

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 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;
  2. Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
  3. End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.

Exclusion Criteria:

  1. Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
  2. Concomitant autoimmune disease;
  3. Superinfection with other hepatitis viruses;
  4. Important organ dysfunctions not due to liver disease or malignancies;
  5. Pregnancy and lactation;
  6. Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
  7. Bioartificial liver support therapy;
  8. Previous liver transplantation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: umbilical cord blood mesenchymal stem cells
Eksperimentel: 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.
Medicin: umbilical cord blood mesenchymal stem cells
Ingen indgriben: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
Tidsramme: 52 weeks
52 weeks
The survival time of patients after UC-MSC infusions.
Tidsramme: 52 weeks
52 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
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
1,2,3,4,8,12,24,36,52weeks
The influence on levels of ALB(g/L) after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
1,2,3,4,8,12,24,36,52weeks
The influence on levels of TBil (umol/L) after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
1,2,3,4,8,12,24,36,52weeks
The influence on levels of INR after UC-MSC infusions
Tidsramme: 1,2,3,4,8,12,24,36,52weeks
1,2,3,4,8,12,24,36,52weeks
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
1,2,3,4,8,12,24,36,52weeks
The incidence of fatal complications after UC-MSC infusions.
Tidsramme: 52 weeks
52 weeks
Comparison of levels of NKG2A among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of NKG2D among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of NKP46 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of perforin among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of FasL among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks
Comparison of levels of gramzymeB among the groups after UC-MSC infusions
Tidsramme: 2,4,8,12,24,36,52 weeks
2,4,8,12,24,36,52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2016

Primær færdiggørelse (Forventet)

1. juni 2017

Studieafslutning (Forventet)

1. juni 2018

Datoer for studieregistrering

Først indsendt

27. maj 2016

Først indsendt, der opfyldte QC-kriterier

21. juni 2016

Først opslået (Skøn)

24. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCBMSC
  • LBingliang (Registry Identifier: Bing-liang Lin)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med Leversvigt

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