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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cirrhoses Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Official Title: Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : June 20, 2023
Estimated Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: intravenous injection of UC-MSC
The dosage of the intravenous route is 100 million MSCs for each subject.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Examination of liver function [ Time Frame: 1 month after injection ]
    assessed from SGOT and SGPT values in laboratory tests result

  5. Examination of liver function [ Time Frame: 3 months after injection ]
    assessed from SGOT and SGPT values in laboratory tests result

  6. Examination of liver function [ Time Frame: 6 months after injection ]
    assessed from SGOT and SGPT values in laboratory tests result

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357600


Contacts
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Contact: Chyntia O Jasirwan, PhD 08121058683 chyn.madu@gmail.com
Contact: Cynthia R Sartika, M.Sc c.sartika@gmail.com

Locations
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Indonesia
Cipto Mangunkusumo hospital Recruiting
Jakarta, DKI Jakarta, Indonesia
Contact: Wahyu purnomo, GP    082190790535    wahyupurnama@gmail.com   
Contact: Rima Haifa, B.Sc    085717109438    asct.prostem@gmail.com   
Principal Investigator: Chyntia O jasirwan, PhD         
Sponsors and Collaborators
PT. Prodia Stem Cell Indonesia
Investigators
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Principal Investigator: Chyntia O Jasirwan, PhD Cipto Mangunkusumo Hospital, Jakarta
Study Chair: Rima Haifa, B.Sc Prodia Stem Cell Indonesia
More Information
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Responsible Party: PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier: NCT04357600    
Other Study ID Numbers: CT/LC/01/2018
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PT. Prodia Stem Cell Indonesia:
Allogeneic Mesenchymal Stem Cell
Umbilical Cord Mesenchymal Stem Cell
liver cirrhosis due to type B hepatitis
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes