Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis

NCT05871463 | Unknown Phase 2 DMC

• 1 other identifier: 1208
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, mesenchymal stem cell (MSC) transfusion has been shown to lead to the regression of liver fibrosis in mice and humans. However, little is known about MSC-exosome therapy. We will evaluate the therapeutic potential of mesenchymal stem Cell-Exosomes as an alternative to cell therapy in Cirrhotic patients. This study examined the safety and efficacy of umbilical cord-derived MSC-exosomes in patients with decompensated LC.

Conditions

Decompensated Liver Cirrhosis

Outcome Measures

Primary Outcomes (6)

• Liver function by MELD score

  Calculation of MELD score based on patient's laboratory values for serum creatinine, bilirubin, international normalized ratio for prothrombin time, and sodium.

  Baseline

• Liver function by MELD score

  Calculation of MELD score based on patient's laboratory values for serum creatinine, bilirubin, international normalized ratio for prothrombin time, and sodium.

  after 2 months of the trial

• Liver function by MELD score

  Calculation of MELD score based on patient's laboratory values for serum creatinine, bilirubin, international normalized ratio for prothrombin time, and sodium.

  after 4 months of the trial

• Liver function by CHILD score

  Calculation of CHILD score based on patient's laboratory values for serum bilirubin, albumin, international normalized ratio for prothrombin time, ascites, and encephalopathy.

  Baseline

• Liver function by CHILD score

  Calculation of CHILD score based on patient's laboratory values for serum bilirubin, albumin, international normalized ratio for prothrombin time, ascites, and encephalopathy.

  after 2 months of the trial

• Liver function by CHILD score

  Calculation of CHILD score based on patient's laboratory values for serum bilirubin, albumin, international normalized ratio for prothrombin time, ascites, and encephalopathy.

  after 4 months of the trial

Secondary Outcomes (4)

• Change in liver enzyme AST

  Baseline, after 2 and 4 months of the trial

• Change in liver enzyme ALT

  Baseline, after 2 and 4 months of the trial

• international normalized ratio (INR) for prothrombin time

  Baseline, after 2 and 4 months of the trial

• Bilirubin

  Baseline, after 2 and 4 months of the trial

Study Arms (1)

Exosome

EXPERIMENTAL

Standard medication + MSC-derived exosomes at a final dose of 40mg in three weeks

Biological: MSC-derived exosomes

Interventions

MSC-derived exosomes BIOLOGICAL

Patients will receive standard medication plus MSC-derived exosomes at a final dose of 40mg in three weeks. Standard medication includes: a) treatment of the underlying cause of cirrhosis such as drug treatment of hepatitis B and C. b) symptomatic treatment of port complications such as ascites, prevention of variceal bleeding, treatment and prevention of hepatic encephalopathy.

Exosome

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to voluntarily sign an informed consent form (ICF) authorization.
• Males or females between 18-75 years old with a clinically confirmed diagnosis of Liver cirrhosis with any etiology, except viral cirrhosis.
• Child score class B or C.

You may not qualify if:

• Known cardiovascular disease.
• a) History of hepatocellular carcinoma (HCC). b) History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous carcinoma at the time of Screening visit. c) Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening visit.
• Females who are pregnant or breastfeeding.
• Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons).
• Use of any experimental medications within the last 6 months of Screening Visit.
• Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements.
• Weight loss of \>5% within 6 months prior to Screening, based on subject's reporting.
• Currently or participated in a weight loss program within the last 6 months.
• Any history of bariatric surgery.
• Diabetes mellitus Type I.
• Daily alcohol intake \>20 ml (2 units)/day for women and 30 ml (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire at Screening and plan to consume the same alcohol amount referenced above during the trial.
• Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \>10 mg prednisone-equivalent concurrently or within 1 year prior to Screening.
• Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator.
• Uncontrolled arterial hypertension.
• Any severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• Research Institute for Gastroenterology and Liver Diseases (RIGLD): lead

Study Sites (1)

Research Institute of Gastroenterology & Liver Diseases

Tehran, 1985714711, Iran

RECRUITING

Study Officials

• Behzad Hatami, MD

  Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti Medical University, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaveh Baghaei, Ph.D.

CONTACT

+98 21 2243 2516; kavehbaghai@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 23, 2023
• Study Start: May 26, 2023
• Primary Completion: August 11, 2023
• Study Completion: December 11, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

IR (1)