Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-10-31

Brief Summary

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Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched liver. Stem cell transplantation instead of conventional medical therapy or orthotopic liver transplantation will be a promising alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs) are generally thought of as an autologous source of regenerative cells in previous studies.In this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for patients with liver cirrhosis will be evaluated.

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Detailed Description

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The purpose of this study is to show whether menstrual blood-derived stem cells can improve the disease conditions in patients with liver cirrhosis.

One of two treatment arms will be assigned to the patients. One group will receive 2 weeks of conventional therapy plus MenSCs treatment; The other group will receive 2 weeks of conventional therapy plus placebo treatment.

MenSCs will be cultured and collected in a GMP lab. Patients were strictly monitored after the cells injection via i.v.. Patients are followed up at intervals up to at least 2 years.Clinical parameters such as ascites volume,serum alanine aminotransferase,total bilirubin,prothrombin time,albumin,MELD score,and Child-Pugh score will be evaluated at each timepoint.

Conditions

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Liver Cirrhosis Fibrosis Liver Disease Digestive System Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Conventional therapy plus MenSCs treatment

Group Type EXPERIMENTAL

conventional therapy plus MenSC transplantation

Intervention Type BIOLOGICAL

patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine.

MenSCs transplantation: taken i.v., twice per week, at a dose of 1\*10E6 MSC/kg body for 2 weeks.

No intervention

Conventional therapy plus placebo treatment:

Oral or intravenous administration

Group Type ACTIVE_COMPARATOR

Conventional therapy plus placebo treatment

Intervention Type DRUG

25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Interventions

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conventional therapy plus MenSC transplantation

patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine.

MenSCs transplantation: taken i.v., twice per week, at a dose of 1\*10E6 MSC/kg body for 2 weeks.

Intervention Type BIOLOGICAL

Conventional therapy plus placebo treatment

25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Intervention Type DRUG

Other Intervention Names

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Interferon Bifendatatum Ursodeoxycholic Acid Menstrual blood-derived stem cells(MenSCs) Interferon Bifendatatum Ursodeoxycholic Acid

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Aged 20 to 50years
* Liver cirrhosis
* Negative pregnancy test

Exclusion Criteria

* Pregnant or lactating women
* Malignancies
* Sepsis
* Vital organs failure
* Severe bacteria infection
* Vascular thromboses in the portal or hepatic veins

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No