Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B

Официальное название

Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study

Обзор

The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.

Подробное описание

The study is investigating the effect and safety of stem cells therapy in patients with liver cirrhosis that is specifically caused by Hepatitis B infection, the participants will be chosen based on inclusive and exclusive criteria to ensure the eligibility of the patients for this study. The patients will be given therapy in the form of allogeneic mesenchymal stem cells transplantation, the stem cells in this study were provided from Prodia Stem Cell Indonesia (ProSTEM). The stem cells being will also be subjected to certain criteria to ensure the utmost safety. The data of this study will be derived from the observation results of the patients' liver damage status in weeks 4, 6 and 12. Aside from that, hemodynamic will be conducted as a part of the observation

Вмешательства

• Биопрепарат Allogeneic Umbilical Cord Mesenchymal Stem Cell
  All research samples will be treated by Intravenous injection of allogeneic mesenchymal stem cells and hemodynamic observation will be done for 24 hours after treated. Periodic post-treatment observation will be done on 1st month, 3rd month, and 6th month after therapy. The Independent variable in this research is Child-Pugh B Cirrhosis caused by Hepatitis B, while the dependent variable is the degree of liver function damage consisting of an examination of liver function, Child-Pugh score, and

Первичные конечные точки

• Child Pugh Score [Срок оценки: 1 month after injection]
• Child Pugh Score [Срок оценки: 3 months after injection]
• Child Pugh Score [Срок оценки: 6 months after injection]
• Examination of liver function [Срок оценки: 1 month after injection]
• Examination of liver function [Срок оценки: 3 months after injection]
• Examination of liver function [Срок оценки: 6 months after injection]
• MELD Score [Срок оценки: 1 month after injection]
• MELD Score [Срок оценки: 3 months after injection]
• MELD Score [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients with decompensated cirrhosis (Child-Pugh B) caused by hepatitis B infection (Cirrhosis is evidenced by the results of ultrasonography examination and chronic hepatitis B infection is found in patients who are taking hepatitis B drugs)

Критерии исключения

• Patients who refuse to participate in research
• Having malignancies disease, both liver malignancies or other malignancies
• Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV).
• Pregnant or lactation patients as evidenced by positive pregnancy test results
• Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease
• Having the case of alcohol dependence and NASH
• Patients who have undergone transplantation and other stem cell therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Cipto Mangunkusumo hospital — Jakarta

Идентификаторы

NCT: NCT04357600 · CT/LC/01/2018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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