Umbilical Cord-derived Mesenchymal Stem Cell Infusion in the Management of Adult Liver Cirrhosis

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 1

Conditions: Liver Cirrhosis

Treatments: Biological: Human umbilical cord-derived mesenchymal stem cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05331872

ISC.19.29

Details and patient eligibility

About

This is a phase I, open label, single arm trial using UC-MSCs to treat patients with liver cirrhosis that includes 20 patients. The primary outcome measure will be change in MELD score at 3, 6, and 12 months after UC-MSC transplantation from baseline. The safety is assessed by frequency and severity of the adverse event or serious adverse event associated with stem cell injection. This study could reconfirm the efficacy of stem cell transplantation for liver cirrhosis and would open a novel cell therapy for the treatment of adult liver cirrhosis.

Full description

Liver cirrhosis is defined as the histological development of regenerative nodules surrounded by fibrous bands and causes by many forms of liver diseases and conditions such as hepatitis and chronic alcoholism. Liver cirrhosis has become one of the major causes of morbidity and mortality with over one million people died due to cirrhosis in 2010 worldwide. Currently, the only curative treatment for end-stage liver disease is liver transplantation. However, the shortage in donor organ availability and the side-effect associated with long-term immunosuppression after transplant requires the development of new alternative therapies for liver cirrhosis. Recent clinical trials demonstrate that bone marrow-derived stem cells (BMDSCs) as well as umbilical cord-derive mesenchymal stem cells (UC-MSCs) improve liver function in patients with liver cirrhosis. In Vietnam, however, there are no clinical trials to date that investigate the potential of UC-MSCs for liver cirrhosis management. This is a phase I, open label, single arm trial using UC-MSCs to treat patients with liver cirrhosis that includes 20 patients. The primary outcome measure will be change in MELD score at 3, 6, and 12 months after UC-MSC transplantation from baseline. The safety is assessed by frequency and severity of the adverse event or serious adverse event associated with stem cell injection. This study could reconfirm the efficacy of stem cell transplantation for liver cirrhosis and would open a novel cell therapy for the treatment of adult liver cirrhosis

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 to 70 years old.
• Patients diagnosed of liver cirrhosis: splenomegaly, elevated hepatic enzymes and/or esophageal varices detected by endoscopy, or liver biopsy demonstrated liver cirrhosis
• Be willing to complete the study and sign the consent form.

Exclusion criteria

• Younger than 18 or older than 70 years old
• Recent infection
• Patients with history of chronic diseases such as cancer, chronic hepatitis, chronic kidney disease.
• Any clinically significant blood coagulation disorder(s)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

human umbilical cord-derived mesenchymal stem cell transplantation for patients with liver cirrhosis

Experimental group

Description:

Umbilical cords from healthy donor are processed with 24 hours after vaginal delivery. The cords are delivered in a sterilized jar the laboratory to process. After washing in PBS to remove any contaminating blood, the cord is cut into small pieces. The pieces are minced and digested by enzyme. The UC-MSCs is cultured and expanded using commercially available serum-free and xeno-free medium at 37°C in a humidified atmosphere with 5% CO2. The UC-MSCs is suspended in 15 ml of saline buffer

Treatment:

Biological: Human umbilical cord-derived mesenchymal stem cell infusion