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Safety of UC-MSC Transfusion for ACLF Patients

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ClinicalTrials.gov Identifier: NCT04822922
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Hai Li, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Acute on chronic liver failure (ACLF) is a type of critically ill liver disease with high short-term mortality in liver disease. Liver transplantation is currently the only method to improve survival. Current clinical research evidence shows that mesenchymal stem cells can reduce the mortality of ACLF patients and are safe. This study aims to explore the safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of ACLF. The study population is ACLF patients with 1-2 organ failures. To explore the safety of 3 doses of UC-MSCs, 16 patients need to be enrolled. The main observation indicators are the short-term and long-term safety of the treatment. All patients need to receive the standard medical treatment (SMT) at the same time. Stem cell treatment is given by intravenous infusion on the first, fourth, seventh, and tenth day. The occurrence of adverse events (AE) and serious adverse events(SAE) before and after the infusion will be observed. After the patient is discharged from the hospital, patients will be followed , the follow-up time is 5 years.

Condition or disease Intervention/treatment Phase
Acute-On-Chronic Liver Failure Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 parallel group with different doses of UC-MSC
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Human Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) Transfusion for Acute-on-chronic Liver Failure Patients
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 21, 2024

Arm Intervention/treatment
Experimental: low dose
hUC-MSCs 4*10^5/kg/each time
Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)
The hUC-MSCs were injected intravenously on the 1, 4, 7 and 10 days after patients recruitment. The treatment doses include low dose: 4*10^5 cells/kg/each time, and medium dose: 8*10^5 cells/kg/each time, high dose 12*10^5 cells/kg/each time. After 3 groups of patients were enrolled, the group with appropriate safety and effectiveness was selected and the other 4 subjects were included.

Experimental: middle dose
hUC-MSCs 8*10^5/kg/each time
Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)
The hUC-MSCs were injected intravenously on the 1, 4, 7 and 10 days after patients recruitment. The treatment doses include low dose: 4*10^5 cells/kg/each time, and medium dose: 8*10^5 cells/kg/each time, high dose 12*10^5 cells/kg/each time. After 3 groups of patients were enrolled, the group with appropriate safety and effectiveness was selected and the other 4 subjects were included.

Experimental: high dose
hUC-MSCs 12*10^5/kg/each time
Genetic: Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)
The hUC-MSCs were injected intravenously on the 1, 4, 7 and 10 days after patients recruitment. The treatment doses include low dose: 4*10^5 cells/kg/each time, and medium dose: 8*10^5 cells/kg/each time, high dose 12*10^5 cells/kg/each time. After 3 groups of patients were enrolled, the group with appropriate safety and effectiveness was selected and the other 4 subjects were included.




Primary Outcome Measures :
  1. Safety of treatment [ Time Frame: 1 month since intervention start ]
    The purpose of this trial is to observe the short-term safety of low, medium and high doses of hUC-MSCs in the treatment of ACLF patients. The primary endpoint of the study was serious adverse events that occurred during the course of one month of treatment. If serious adverse reactions(SAE) occur during the treatment in hospital, the intervention will be stopped and the study will be terminated.


Secondary Outcome Measures :
  1. Short-time efficacy of treatment [ Time Frame: 90 days ]
    To assess the efficacy of hUC-MSCs in the treatment of ACLF patients, patients will be followed-up, and the prognosis at each time point will be collected as our schedule.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. . Age 18-70 years old;
  2. . A history of chronic liver disease, chronic acute liver failure (ACLF) caused by various causes, 1-2 organ failure (ACLF diagnosis is based on the European EASL diagnostic criteria, and the organ failure criteria is based on CLIF-OF);
  3. . The patient or adult family members agree to participate in this study and sign an informed consent form;

Exclusion Criteria:

  • Those who meet any of the following conditions will not be included:

    1. Those who intend to undergo artificial liver treatment;
    2. Those who have received liver transplantation and any form of stem cell therapy;
    3. Malignant tumors in or outside the liver; or imaging findings suggest malignant mass in the liver or tuberculosis;
    4. Complicated with severe autoimmune diseases; combined with severe cardiopulmonary insufficiency; renal replacement therapy; Immunosuppressive therapy; HIV/tuberculosis infection; alcohol/drug addiction; participated in drug trials in the past 3 months;
    5. Gastrointestinal bleeding or serious infection occurred in the past one month;
    6. Pregnant and lactating women;
    7. Those who do not have the ability to make independent judgments and have no direct adult family members to sign the informed consent form.

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): NCT04822922


Contacts
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Contact: Hai Li +86-13818525494 haili_17@126.cpm

Locations
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China, Shanghai
Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity,
Shanghai, Shanghai, China
Contact: Hai Li, PhD    +8613818525494    haili_17@126.com   
Sponsors and Collaborators
Hai Li
Investigators
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Study Director: Hai Li Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine
Publications:

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Responsible Party: Hai Li, chief physician of gastroenterological division, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04822922    
Other Study ID Numbers: MSC-ACLF-1
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Hai Li, Shanghai Jiao Tong University School of Medicine:
ACLF
mesenchymal stem cell
safety
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute