Liver CirrhosesPhase 1/2NCT04357600
Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
A Phase 1/2 study testing Allogeneic Umbilical Cord Mesenchymal Stem Cell in people with Liver Cirrhoses, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Allogeneic Umbilical Cord Mesenchymal Stem Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 May 2018to 20 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.
Read the 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
- Conditions
- Liver Cirrhoses
- Being tested
- Allogeneic Umbilical Cord Mesenchymal Stem Cell
- Keywords
- Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, liver cirrhosis due to type B hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Umbilical Cord Mesenchymal Stem CellBiological
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 group | Role | What they receive |
|---|---|---|
| intravenous injection of UC-MSC | Experimental | The dosage of the intravenous route is 100 million MSCs for each subject. Receives: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after injection
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.
Measured: 3 months after injection
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.
Measured: 6 months after injection
Examination of liver function
assessed from SGOT and SGPT values in laboratory tests result
Measured: 1 month after injection
Examination of liver function
assessed from SGOT and SGPT values in laboratory tests result
Measured: 3 months after injection
Examination of liver function
assessed from SGOT and SGPT values in laboratory tests result
Measured: 6 months after injection
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.
Measured: 1 month after injection
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.
Measured: 3 months after injection
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start17 May 2018
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chyntia O Jasirwan, PhD, Principal investigator, Cipto Mangunkusumo Hospital, JakartaRima Haifa, B.Sc, Study chair, Prodia Stem Cell Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357600
- Sponsor's protocol ID
- CT/LC/01/2018
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2020
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
- ClinicalTrials.gov ID
- NCT04357600
- Acronym / sponsor ID
- CT/LC/01/2018
- Conditions
- Liver Cirrhoses
- Keywords
- Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, liver cirrhosis due to type B hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study model is considered as a single group assignment since all the participants are being administered with the same treatment.
| Arm | Type | Receives |
|---|---|---|
| intravenous injection of UC-MSC | Experimental | Biological: Allogeneic Umbilical Cord Mesenchymal Stem CellThe dosage of the intravenous route is 100 million MSCs for each subject. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Umbilical Cord Mesenchymal Stem CellAll 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. | Biological | intravenous injection of UC-MSC |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
Related trials for Liver Cirrhoses
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruiting
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
Cirrhoses, Liver
RecruitingPhase 4
Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver
Cirrhoses, Liver, Decompensated Cirrhosis of Liver
Not yet recruitingObservational study
Detecting Liver Fibrosis in Patients At-risk
Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease
Active, not recruitingObservational study
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chyntia O Jasirwan, PhD principal investigator
Cipto Mangunkusumo Hospital, Jakarta
Rima Haifa, B.Sc study chair
Prodia Stem Cell Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic Umbilical Cord Mesenchymal Stem Cell in people with Liver Cirrhoses, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Pugh Score (time frame: 1 month after injection). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.