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Enrolling by invitationPhase 1/2

Tests umbilical cord stem cells in people with hepatitis B liver cirrhosis

Tests donor umbilical cord stem cells in adults with liver scarring caused by hepatitis B.

Key facts

Who runs it
PT. Prodia Stem Cell Indonesia
Where
Jakarta, IndonesiaSee the site
Trial code
Registry title
Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B
Status
Enrolling by invitation
Phase
Phase 1/2
People taking part
12 people, planned
Started
17 May 2018
Expected to end
20 Dec 2028
Type of study
Interventional
Treatments tested
  • Allogeneic Umbilical Cord Mesenchymal Stem Cell
Record updated
25 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with decompensated liver cirrhosis (Child-Pugh B) caused by hepatitis B. It tests stem cell therapy made from umbilical cord cells.

Age
18 to 65 years
Sex
All sexes can join.
Disease stage
Decompensated liver cirrhosis (Child-Pugh B) caused by hepatitis B infection. Cirrhosis is shown by an ultrasound scan.
Earlier treatment
People must be taking hepatitis B drugs for their chronic hepatitis B infection. People who have had a transplant or other stem cell therapy cannot join.

Main reasons for not taking part

  • Any cancer, in the liver or elsewhere
  • Other infections such as hepatitis C or HIV
  • Pregnant or breastfeeding women
  • Diabetes, severe heart disease, kidney disease or lung disease
  • Alcohol dependence or NASH

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 take part

  • Patients who have undergone transplantation and other stem cell therapy
  • Having malignancies disease, both liver malignancies or other malignancies
  • Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV)
  • Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease
  • Patients who refuse to participate in research
  • Pregnant or lactation patients as evidenced by positive pregnancy test results
  • Having the case of alcohol dependence and NASH

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Indonesia

  • Cipto Mangunkusumo hospitalJakarta, IndonesiaNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • intravenous injection of UC-MSCTreatment being tested

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

    Treatment: Allogeneic Umbilical Cord Mesenchymal Stem Cell

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
Plain-language title
Tests umbilical cord stem cells in people with hepatitis B liver cirrhosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04357600, who can take part
Record updated
25 February 2026