Study of Decompensated Alcoholic Cirrhosis Treatment by Stem Cells

NCT05155657 | Unknown Phase 1 DMC

• 1 other identifier: 2021-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the safety and tolerance of umbilical cord mesenchymal stem cells (UCMSCs) in patients with decompensated alcoholic cirrhosis, and to provide dose basis for subsequent clinical study design. We will also explore the possible mechanism of UCMSCs in the treatment of decompensated alcoholic cirrhosis (DAC).

Conditions

Alcoholic Cirrhosis

Outcome Measures

Primary Outcomes (9)

• Severity and incidence of adverse events (SIAE) on the 3rd day after the first administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  The 3rd day after the first administration

• 1 week SIAE after the first administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  1 week after the first administration

• 3 weeks SIAE after the first administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  3 week after the first administration

• 3 week SIAE after the the second administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  3 weeks after the the second administration

• 1 month SIAE after the last administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  1 month after the last administration

• 3 months SIAE after the last administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  3 months after the last administration

• 6 months SIAE after the last administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  6 months after the last administration

• 12 months SIAE after the last administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  12 months after the last administration

• 24 months SIAE after the last administration

  According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.

  24 months after the last administration

Secondary Outcomes (9)

• Child-Pugh score (effectiveness evaluation index)

  At baseline, 3, 7 and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6 and 12 months after the last administration.

• Survival rate (effectiveness evaluation index)

  12 months after the last administration.

• Liver function (effectiveness evaluation index)

  Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.

• The Model for End-Stage Liver Disease (MELD) score (effectiveness evaluation index)

  Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.

• KPS score (effectiveness evaluation index)

  Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.

Study Arms (3)

Low dose umbilical cord mesenchymal stem cells (UCMSCs)

EXPERIMENTAL

Biological: Conventional therapy plus low dose UCMSCs treatment

Medium dose UCMSCs

EXPERIMENTAL

Biological: Conventional therapy plus medium dose UCMSCs treatment

High dose UCMSCs

EXPERIMENTAL

Biological: Conventional therapy plus high dose UCMSCs treatment

Interventions

Conventional therapy plus low dose UCMSCs treatment BIOLOGICAL

Patients will receive the conventional therapy plus low dose UCMSCs treatment (0.5×10\^6 UCMSCs/kg body)

Low dose umbilical cord mesenchymal stem cells (UCMSCs)

Conventional therapy plus medium dose UCMSCs treatment BIOLOGICAL

Patients will receive conventional therapy plus medium dose UCMSCs treatment (1×10\^6 UCMSCs/kg body)

Medium dose UCMSCs

Conventional therapy plus high dose UCMSCs treatment BIOLOGICAL

Patients will receive conventional therapy plus high dose UCMSCs treatment (2×10\^6 UCMSCs/kg body)

High dose UCMSCs

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18\~60 years old;
• The subject was diagnosed as decompensated alcoholic liver cirrhosis, according to the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis and the Guidelines for the Prevention and Treatment of Alcoholic Liver Disease (2018);
• The subject was previously diagnosed but treatment is ineffective;
• Liver function was in child Pugh grade A or MELD score \< 12;
• Intermittent albumin supplementation and diuretic treatment are required;
• The subject's Albumin level is less than 35g/L, total bilirubin is smaller than 10 times of the upper limit of normal value (hepatocyte hepatitis), or smaller than 15 times of the upper limit of normal value (cholestatic hepatitis or hepatocyte combined with cholestatic hepatitis), prothrombin activity is over 40% (grade II or lower hepatic encephalopathy has been controlled);
• No history of gastrointestinal hemorrhage in the past month;
• The subject understand and voluntarily sign the informed consent.

You may not qualify if:

• The subject is allergic physique, with a history of drug or food allergies, especially those who are allergic to umbilical cord mesenchymal stem cells and any components in excipients;
• The subject suffer acute attack of gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome or infection;
• The subject suffer systemic infection or severe infection during screening;
• Abnormal laboratory examinations results, including blood routine: peripheral blood white blood cell count \<2.0×10\^9/L or \>12×10\^9/L, hemoglobin (Hb) is less than 70% lower limit of the normal value, platelets \<50×10\^9/L ; Liver function: ALT or AST\> 5 times the upper limit of normal; Renal function: Serum Creatinine (sCr)\> 1.5 times the upper limit of normal; in case of abnormality, test shall be repeated;
• Those who were positive for Hepatitis B surface Antigen (HBsAg) or Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody or syphilis antibody during screening;
• Subjects suffer from serious, progressive, or uncontrolled diseases of important organs (including cardiovascular system, liver, lung and kidney), and other autoimmune diseases, malignant tumors, or a history of previous tumors, as well as other diseases that researchers believe that they are not suitable to participate in this clinical study.
• Subject who has received stem cell therapy within 6 months before the screening;
• Subject who has received biotherapy or participated in other clinical studies within 3 months before screening;
• Female subjects who are pregnant, lactating, or premenopausal subject who failed to take medically approved non-drug contraceptive measures (such as intrauterine device, condom, female sterilization) during treatment and within 6 months after the treatment; or have a pregnancy plan within 6 months after the end of the study;
• Male subjects who fail to take medically approved non-drug contraceptive measures (such as male sterilization or condom) during the treatment period and within 6 months after the end of the treatment;
• Other factors that the researchers believe are not suitable for entering the study.

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Jun Cui, MD

  Yantai Yuhuangding Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Cui, MD

CONTACT

86 05356691999; cuijun89@163.com

Peiwen Lian, PhD

CONTACT

86 05356691999; lianpeiwen@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 13, 2021
• Study Start: June 13, 2022
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CN (1)