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Trial record 59 of 7597 for:    stem cells

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

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ClinicalTrials.gov Identifier: NCT03863002
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Tianjin Nankai Hospital
Information provided by (Responsible Party):
Tianjin Weikai Bioeng., Ltd.

Brief Summary:
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Condition or disease Intervention/treatment Phase
Liver Failure, Acute on Chronic Biological: Mesenchymal Stem Cell Phase 1 Phase 2

Detailed Description:
Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: both participants and the study team are unblinded to the treatment allocation
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2022

Arm Intervention/treatment
No Intervention: Standard Medical Treatment
Standard Medical Treatment (SMT): All patients received SMT, including nutritional supplementation; administration of human serum albumin (serum albumin <30 g/L), fresh frozen plasma (200-400 mL/day until the INR was <1.5), S-adenosylmethionine (1.0 g/day); or anti-virus treatment for hepatic viruses-related cases, and appropriate treatment for complications such as infections (including of the respiratory tract, urinary tract, biliary tract, and digestive tract and spontaneous peritonitis), encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome [HRS]).
Experimental: Mesenchymal Stem Cell
Mesenchymal Stem Cell (MSC): The MSC group received infusions of 1.0 to 10x10^5cells/kg MSCs through the peripheral vein once a week for 4 weeks, in addition to SMT.
Biological: Mesenchymal Stem Cell
Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks




Primary Outcome Measures :
  1. survival rate [ Time Frame: 72 weeks after treatment ]
    Number of participants alive


Secondary Outcome Measures :
  1. Adverse reactions [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Number of participants with adverse reactions (e.g. fever, rash, and diarrhea )

  2. White blood cell [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of white blood cell count

  3. Platelet [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of platelet count

  4. Hemoglobin [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of hemoglobin level

  5. Creatinine [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of creatinine level as a surrogate marker of liver function

  6. ALT [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of alanine aminotransferase (ALT) level as a marker of liver function

  7. ALB [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of albumin (ALB) level as a maker of liver function

  8. TBil [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of total Bilirubin (TBil) level as a marker of liver function

  9. INRs [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of international normalized ratio (INRs) level as a marker of liver function

  10. AFP [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Change of alpha fetoprotein (AFP) level as a marker of liver function

  11. MELD scores [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Model for End-Stage Liver Disease (MELD) score for assessing the severity of chronic liver disease is measured as absolute change to baseline score

  12. Tumor formation [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Number of participants with hepatocellular carcinoma or extrahepatic malignant tumors

  13. Liver failure-associated serious complications [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 48 ]
    Number of participants with liver failure-associated serious complications, such as infections, encephalopathy, gastrointestinal bleeding and HRS



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent
  2. Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin [TBil] ≥10 X the upper limit of normal; coagulopathy (international normalized ratio [INR] ≥1.5 or prothrombin activity [PTA] <40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.
  3. Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);
  4. Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
  5. Body weight ≥50kg

Exclusion Criteria:

  1. Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);
  2. Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;
  3. Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);
  4. Tumor diagnosed by ultrasound, CT, MR examination;
  5. Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)
  6. Extrahepatic cholestasis
  7. Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound
  8. Artificial liver support
  9. Previous liver transplantation
  10. Drug abuse in the past 5 years;
  11. Mental disorders and/or has a family history of mental disorder.
  12. HIV infection
  13. Pregnant or breast-feeding females
  14. Highly allergic
  15. Patients can not cooperate or mobility
  16. Enrolled in other clinical trials with 3 months
  17. Patients who can not provide prior informed consent or refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863002


Contacts
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Contact: Xiuli Cong, MD, PhD +86 18512507567 cong_xiuli@163.com

Locations
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China, Tianjin
Tianjin Weikai Bioeng., Ltd. Not yet recruiting
Tianjin, Tianjin, China
Contact: Xiuli Cong, MD, PhD    +86 18512507567    cong_xiuli@163.com   
Sponsors and Collaborators
Tianjin Weikai Bioeng., Ltd.
Tianjin Nankai Hospital

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Responsible Party: Tianjin Weikai Bioeng., Ltd.
ClinicalTrials.gov Identifier: NCT03863002     History of Changes
Other Study ID Numbers: Tianjin Weikai Bioeng., Ltd
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Weikai Bioeng., Ltd.:
mesenchymal stem cell
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases