Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

Sun Yat-sen University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Failure

Treatments: Other: Conventional plus UC-MSC treatment; Other: Conventional plus PE treatment; Other: Conventional treatment; Other: Conventional plus UC-MSC and PE therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01724398

UCMSC-PE

Details and patient eligibility

About

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.

Full description

To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.

Enrollment: 120 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Acute-on-Chronic liver failure caused by hepatitis B virus
• Model for End-Stage Liver Disease (MELD) <30

Exclusion criteria

• Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
• History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
• Severe problems in other vital organs(e.g. the heart, renal or lungs)
• Severe bacteria infection
• Tumor on ultrasonography, CT or MRI examination
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Conventional treatment

Experimental group

Description:

Participants will receive conventional treatment and then be followed until the week 48 study visit.

Treatment:

Other: Conventional treatment

Conventional plus UC-MSC treatment

Experimental group

Description:

Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.

Treatment:

Other: Conventional plus UC-MSC treatment

Conventional plus PE treatment

Experimental group

Description:

Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.

Treatment:

Other: Conventional plus PE treatment

Conventional plus UC-MSC and PE therapy

Experimental group

Description:

Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit.

Treatment:

Other: Conventional plus UC-MSC and PE therapy