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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357600
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

Tracking Information
First Submitted Date  ICMJE March 8, 2020
First Posted Date  ICMJE April 22, 2020
Last Update Posted Date June 15, 2022
Actual Study Start Date  ICMJE May 17, 2018
Estimated Primary Completion Date June 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • Child Pugh Score [ Time Frame: 1 month after injection ]
    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 [ Time Frame: 3 months after injection ]
    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 [ Time Frame: 6 months after injection ]
    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 [ Time Frame: 1 month after injection ]
    assessed from SGOT and SGPT values in laboratory tests result
  • Examination of liver function [ Time Frame: 3 months after injection ]
    assessed from SGOT and SGPT values in laboratory tests result
  • Examination of liver function [ Time Frame: 6 months after injection ]
    assessed from SGOT and SGPT values in laboratory tests result
  • MELD Score [ Time Frame: 1 month after injection ]
    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 [ Time Frame: 3 months after injection ]
    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 [ Time Frame: 6 months ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
Official Title  ICMJE Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhoses
Intervention  ICMJE Biological: 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 MELD score.
Study Arms  ICMJE Experimental: intravenous injection of UC-MSC
The dosage of the intravenous route is 100 million MSCs for each subject.
Intervention: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)		 12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2023
Estimated Primary Completion Date June 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chyntia O Jasirwan, PhD 08121058683 chyn.madu@gmail.com
Contact: Cynthia R Sartika, M.Sc c.sartika@gmail.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04357600
Other Study ID Numbers  ICMJE CT/LC/01/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party PT. Prodia Stem Cell Indonesia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PT. Prodia Stem Cell Indonesia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chyntia O Jasirwan, PhD Cipto Mangunkusumo Hospital, Jakarta
Study Chair: Rima Haifa, B.Sc Prodia Stem Cell Indonesia
PRS Account PT. Prodia Stem Cell Indonesia
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP