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

Primary Purpose

Liver Cirrhoses

Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Allogeneic Umbilical Cord Mesenchymal Stem Cell
Sponsored by
PT. Prodia Stem Cell Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhoses focused on measuring Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, liver cirrhosis due to type B hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravenous injection of UC-MSC

Arm Description

The dosage of the intravenous route is 100 million MSCs for each subject.

Outcomes

Primary Outcome Measures

Child Pugh Score
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Child Pugh Score
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Child Pugh Score
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Examination of liver function
assessed from SGOT and SGPT values in laboratory tests result
Examination of liver function
assessed from SGOT and SGPT values in laboratory tests result
Examination of liver function
assessed from SGOT and SGPT values in laboratory tests result
MELD Score
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
MELD Score
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
MELD Score
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2020
Last Updated
June 12, 2022
Sponsor
PT. Prodia Stem Cell Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04357600
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses
Keywords
Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, liver cirrhosis due to type B hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
The study model is considered as a single group assignment since all the participants are being administered with the same treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous injection of UC-MSC
Arm Type
Experimental
Arm Description
The dosage of the intravenous route is 100 million MSCs for each subject.
Intervention Type
Biological
Intervention Name(s)
Allogeneic Umbilical Cord Mesenchymal Stem Cell
Intervention Description
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 MELD score.
Primary Outcome Measure Information:
Title
Child Pugh Score
Description
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Time Frame
1 month after injection
Title
Child Pugh Score
Description
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Time Frame
3 months after injection
Title
Child Pugh Score
Description
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Time Frame
6 months after injection
Title
Examination of liver function
Description
assessed from SGOT and SGPT values in laboratory tests result
Time Frame
1 month after injection
Title
Examination of liver function
Description
assessed from SGOT and SGPT values in laboratory tests result
Time Frame
3 months after injection
Title
Examination of liver function
Description
assessed from SGOT and SGPT values in laboratory tests result
Time Frame
6 months after injection
Title
MELD Score
Description
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
Time Frame
1 month after injection
Title
MELD Score
Description
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
Time Frame
3 months after injection
Title
MELD Score
Description
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chyntia O Jasirwan, PhD
Phone
08121058683
Email
chyn.madu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia R Sartika, M.Sc
Email
c.sartika@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chyntia O Jasirwan, PhD
Organizational Affiliation
Cipto Mangunkusumo Hospital, Jakarta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rima Haifa, B.Sc
Organizational Affiliation
Prodia Stem Cell Indonesia
Official's Role
Study Chair
Facility Information:
Facility Name
Cipto Mangunkusumo hospital
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wahyu purnomo, GP
Phone
082190790535
Email
wahyupurnama@gmail.com
First Name & Middle Initial & Last Name & Degree
Rima Haifa, B.Sc
Phone
085717109438
Email
asct.prostem@gmail.com
First Name & Middle Initial & Last Name & Degree
Chyntia O jasirwan, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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