Clinical trial NCT04357600: Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
Official title: Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhoses
Keywords: Allogeneic Mesenchymal Stem Cell
Umbilical Cord Mesenchymal Stem Cell
liver cirrhosis due to type B hepatitis
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study model is considered as a single group assignment since all the participants are being administered with the same treatment.
Primary purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Child Pugh Score
timeFrame: 1 month after injection
measure: Child Pugh Score
timeFrame: 3 months after injection
measure: Child Pugh Score
timeFrame: 6 months after injection
measure: Examination of liver function
timeFrame: 1 month after injection
measure: Examination of liver function
timeFrame: 3 months after injection
measure: Examination of liver function
timeFrame: 6 months after injection
measure: MELD Score
timeFrame: 1 month after injection
measure: MELD Score
timeFrame: 3 months after injection
measure: MELD Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo hospital
state: DKI Jakarta
Study officials:
affiliation: Cipto Mangunkusumo Hospital, Jakarta
name: Chyntia O Jasirwan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prodia Stem Cell Indonesia
name: Rima Haifa, B.Sc
role: STUDY_CHAIR
References: