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Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1b)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05984303
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Collaborator:
Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital

Study Description
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Brief Summary:
This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Biological: Human Umbilical Cord-derived Mesenchymal Stem Cells Phase 1

Detailed Description:
Decompensated cirrhosis has a high overall mortality rate. There is unmet need for safe and alternative therapeutic potions. This clinical trial is a Phase 1, multiple administration, dose-escalasion clinical trial of human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis. The primary objective of this study is to assess the safety of intravenous infusion of human umbilical cord-derived mesenchymal stem cells in patients with decompensated cirrhosis.In order to illustrate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells and the patient's dose tolerance to human umbilical cord-derived mesenchymal stem cells.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Decompensated Cirrhosis Using Human Umbilical Cord-derived Mesenchymal Stem Cells: A Phase 1, Multiple Administration, Dose-escalasion Trial (MSC-DLC-1b)
Estimated Study Start Date : August 30, 2023
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Human Umbilical Cord-derived Mesenchymal Stem Cells
Standard of care (SOC) plus a multiple administration and dose-escalasion with 2 cohorts with 3 subjects/cohort who receive doses of 1 and 2 ×10E8 cells. Each person received 3 infusions, 1 week apart, Proceed from lower dose to higher dose if no safety concerns for each cohort.
 Biological: Human Umbilical Cord-derived Mesenchymal Stem Cells
Human Umbilical Cord-derived Mesenchymal Stem Cells will be administered intravenously.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: from baseline to 28th day ]
  2. incidence of dose-limiting toxicity-related adverse events [ Time Frame: from baseline to 28th day ]
  3. maximum tolerated dose [ Time Frame: from baseline to 28th day ]
  4. Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day [ Time Frame: at 28th day ]

    The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology.

    The MELD score is calculated by the formula: R = 9.6 × ln (creatinine mg/dl) + 3.8 × ln (bilirubin mg/dl) + 11.2 × ln (INR) + 6.4 × etiology, and the results are taken as integers. ( 0 for cholestatic and alcoholic cirrhosis and 1 for other causes of cirrhosis such as viruses).



Secondary Outcome Measures :
  1. Change in Model for End-Stage Liver Disease (MELD) score from baseline to 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months [ Time Frame: 3 days, 7days, 14 days, 21 days, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, and 24 months ]
  2. Incidence of each complication associated with decompensated cirrhosis [ Time Frame: up to 24 months ]
  3. liver transplant-free survival [ Time Frame: up to 24 months ]
  4. Incidence of liver failure [ Time Frame: up to 24 months ]
  5. plasma albumin (ALB) [ Time Frame: up to 24 months ]
  6. plasma prealbumin (PALB) [ Time Frame: up to 24 months ]
  7. total bilirubin (TBIL) [ Time Frame: up to 24 months ]
  8. serum cholinesterase (CHE) [ Time Frame: up to 24 months ]
  9. prothrombin time (PT) [ Time Frame: up to 24 months ]
    Prothrombin time (PT) is a blood test that measures the time it takes for plasma to clot, to check for bleeding problems, or to check whether medicine to prevent blood clots is working.

  10. Child-Turcotte-Pugh (CTP) score [ Time Frame: up to 24 months ]

    Child-Turcotte-Pugh (CTP) score is a scoring system that evaluates the liver function.

    Maximum is 15, minimum is 5. Higher scores mean a worse outcome.


  11. EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) [ Time Frame: up to 24 months ]
    Quality of life assessment. Maximum is 5, minimum is 1. Lower scores mean a better outcome.

  12. Incidence of liver cancer [ Time Frame: up to 24 months ]
  13. ChronicLiver Disease Questionnaire (CLDQ) [ Time Frame: up to 24 months ]
    Quality of life assessment. The Chronic Liver Disease Questionnaire (CLDQ) was developed as an evaluative instrument to measure longitudinal change in health status within individuals with chronic liver disease. In addition to measuring both physical and mental health, the instrument was designed to be a disease-specific tool for assessing areas of function important to patients with chronic liver disease. Maximum is 7, minimum is 1. Higher scores mean a better outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to provide written informed consent;
  2. Aged 18 to 75 years (including 18 and 75 years), male or female;
  3. Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);
  4. Child-Turcotte-Pugh (CTP) score 7 to 12 points.

Exclusion Criteria:

  1. Hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening, or patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months.
  2. Hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening, or patients with hepatitis C virus-related decompensated liver cirrhosis not more than 12 months on antiviral therapy.
  3. Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.
  4. Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.
  5. Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.
  6. Patients with biliary obstruction, or portal patients with vein spongiosis.

  7. Patients are known with other malignancies within 5 years prior to the signing of ICF, except have had curative therapy of Basal Cell Cancer, Squamous Cell Carcinoma and/or radical resection of Carcinoma in Situ.

    Known to have had other malignancies within 5 years prior to signing the informed consent, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ with curable resection.

  8. Patients with history of organ transplantation.
  9. Patients with severe heart, lung, kidney and blood system diseases.
  10. Patients with drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.
  11. Patients with history of immunodeficiency disease, including a positive test result for human immunodeficiency virus (HIV) antibodies, or other acquired or congenital immunodeficiency diseases;
  12. Pregnant or lactating female. Fertile patients who were unable or unwilling to use effective non-pharmaceutical contraception during the trial and within 6 months after the end of the trial.
  13. Patients who had cardiovascular and cerebrovascular events (such as Unstable Angina, Brain Hemorrhage, severe Ischemic Infarction) within 3 months before the first dose；Patients who had Myocardial Infarct or a clinically significant Arrhythmia/Conduction Abnormalities within 12 months before the first dose.
  14. Patients with hypersensitivity (allergic to more than two foods or drugs) or with a history of severe allergy, or patients with Severe allergy to a known experimental drug or to any excipient.
  15. Patients previously received stem cell therapy or are intolerance to cell therapy;
  16. Participants in other clinical trials within the last 3 months.
  17. Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.
Contacts and Locations
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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): NCT05984303


Contacts
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Contact: Lei Shi, MD,PhD 86-10-66949623 shilei302@126.com
Contact: Fu-Sheng Wang, MD,PhD 86-10-66933332 fswang302@163.com

Locations
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China
Beijing 302 Hospital
Beijing, China
Contact: Lei Shi, MD,PhD    86-10-66949623    shilei302@126.com   
Sponsors and Collaborators
Beijing 302 Hospital
Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
Investigators
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Study Chair: Fu-Sheng Wang, MD, PhD Beijing 302 Hospital
More Information
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Responsible Party: Fu-Sheng Wang, Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor, Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT05984303    
Other Study ID Numbers: MSC-DLC-1b
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases