Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B
| 1. Background | |
|---|---|
| Registration Number | INA-2SF65XP7 |
| Date of registry approval | 02-06-2025 |
| Registration Date | 30-05-2025 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B |
| Public (popular study title) | Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Prodia StemCell Indonesia |
| Source(s) of monetary or material support | PT Prodia StemCell Indonesia |
| Other partners | RSUPN Dr Cipto Mangunkusumo |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | dr. Chyntia Olivia Maurine Jasirwan, SpPD-KGEH., MARS., Ph.D |
| City | Central Jakarta |
| Country | Indonesia |
| Principal investigator's affiliation | Department of Internal Medicine, Faculty of Medicine-University of Indonesia, Dr. Cipto Mangunkusumo National Hospital, Jakarta |
| Principal Investigator's email address | chyn.madu@gmail.com |
| Public Queries | |
| Contact person name for public queries | Rima Haifa, S.Si, M. Farm-Klin |
| Address for public queries | ProSTEM (Prodia Stem Cell Indonesia) Jl. Kramat VII No.11-13, RT.5/RW.1 10430 Senen Jakarta Pusat, DKI Jakarta |
| City | Central Jakarta |
| Country | Indonesia |
| ZIP | 10430 |
| Affiliation for public queries | PT Prodia StemCell Indonesia |
| Email address for public queries | marketing.rbt@prostem.co.id |
| Phone number for public queries | 6288213178987 |
| Scientific Queries | |
| Name of Contact for scientific queries | Rima Haifa, S.Si., M.Farm-Klin |
| Address for scientific queries | ProSTEM (Prodia Stem Cell Indonesia) Jl. Kramat VII No.11-13, RT.5/RW.1 10430 Senen Jakarta Pusat, DKI Jakarta |
| City | Central Jakarta |
| Country | Indonesia |
| ZIP | 10430 |
| Affiliation of scientific queries contact | PT Prodia StemCell Indonesia |
| Email address for scientific queries | marketing.rbt@prostem.co.id |
| 4. IRB & Regulatory | |
| Ethical Approval number | KET-0097/UN2.F1/ETIK/2018 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan RSUPN Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 16-08-2024 |
| Contact details of Ethic Committee (phone, email, and office) | (021) 3157008 |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | Not applicable |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | RSUPN Dr Cipto Mangunkusumo |
| Recruitment status | Recruit |
| Date of first enrollment | 08-05-2018 |
| Targeted Sample size | 00010 - |
| Number of enrolled participants | 5 |
| Date of study completion (last participant, last visit) | |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Cirrhosis due to chronic hepatitis B |
| Purpose of the study | Treatment |
| Study type | Interventional |
| Interventional Study category | Clinical trial |
| Study phase | Phase 1-2 |
| Method of allocation | Not Applicable (single arm study) |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | No (open) |
| Study intervention (study arm) | This study is a Phase I–II uncontrolled experimental trial investigating the effectiveness of allogeneic umbilical cord–derived mesenchymal stem cell transplantation in patients with cirrhosis due to chronic hepatitis B. |
| Control intervention (control arm) | No control intervention |
| Intervention assignment | Single arm |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 18 |
| Maximum age | 65 |
| Inclusion criteria | a) Patients aged 18–65 years
b) Patients with decompensated cirrhosis (Child-Pugh B) due to hepatitis B infection: -Cirrhosis confirmed by ultrasonographic examination -Chronic hepatitis B infection indicated by ongoing antiviral treatment for hepatitis B |
| Exclusion criteria | a) Refusal to participate in the study
b) Presence of malignancy, including liver or other types of cancer c) Co-infection with other diseases such as hepatitis C or Human Immunodeficiency Virus (HIV) d) Pregnant or lactating patients, confirmed by a positive pregnancy test e) Presence of complications such as diabetes mellitus, severe heart disease, kidney disease, or respiratory illness f) Cases of alcohol dependence or non-alcoholic steatohepatitis (NASH) g) Patients who have previously undergone transplantation or other stem cell therapies. |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Improvement is assessed based on the degree of liver function recovery, including liver function tests, Child-Pugh scores, and MELD scores. |
| Metric/method of measurement | Lab Observation (Liver Function), USG, Child Pugh Score, MELD Score |
| Timepoint(s) of measurement | Basline, 4th week, 12th week, 24th week |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | Subjects with Cirrhosis due to chronic hepatitis B |
| Adverse events | |
| Outcome measures | |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | No |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Specified |