Liver CirrhosisPhase 1NCT06629909
Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration: a Single Center, Randomized, Phase I Clinical Trial
A Phase 1 study testing Secretome in people with Liver Cirrhosis, run by Baermed at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are: 1. How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients? 2. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2024to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age above 17 years, both men and women
- Patient is willing to participate and sign informed consent
- Patient is diagnosed with liver cirrhosis confirmed by clinical examination and diagnostic imaging
- Liver cirrhosis patient with Child-Pugh Class B
- Patient is in a stable condition without life threatening complications such as active gastrointestinal bleeding, severe infection, severe renal failure (eGFR\&>30) at time of registration
- Patient is not receiving experimental drugs for liver cirrhosis for the past 6 months
- Patient is able and willing to comply with research protocol including follow up visits and evaluations
Who cannot join
- Patient with uncontrolled psychiatric disorders
- Patient who is diagnosed with hepatic or non- hepatic malignancy
- Lactating and pregnant patient
- Patient who has allergy or hypersensitivity reaction towards secretome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration a Single Center, Non-randomized, Phase I Clinical Trial
The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are:
- How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients?
- How effective is secretome injection in liver fibrosis 6 months after injection?
- Does secretome injection improve liver function after 6 months after Injection?
- Does secretome injection affect Child Turcotte Pugh score?
- How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis?
- How does secretome injection affect the quality of life in live cirrhosis patient?
- What is the relationship between secretome injection and encephalopathy? Researchers will compare secretome injection group (patients who recieve secretome injections) to best practice treatment group (patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid)
Read more
Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored and given their usual drugs)
Patients will:
Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. Do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, IL-6, TNF alfa and blood test for albumin, SGOT, SGPT, direct bilirubin, indirect bilirubin, INR, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte.
Visit the clinic once every two weeks to receive drugs and treatment for 4 months.
Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)
- Conditions
- Liver Cirrhosis
- Being tested
- Secretome
- Keywords
- liver cirrhosis, secretome, stem cells, HUCMSC
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretomeDrug
Also called hepatoprotector drugs, ursodeoxycholic acid
3 ml Injection of secretome for 8 times two weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Secretome Injection | Experimental | patient will receive secretome injection every two weeks for four months Receives: Drug: Secretome |
| Best Treatment Practice | No intervention | patient will receive hepatoprotector drugs and Urodeoxycolate acid for four months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fibroscan and M2BPGi six month after secretome injections
Patients achieved a response if there are changes in Fibroscan and M2BPGi after secretome injections within six months.best outcome when the M2BPGi Fibroscan decrease, worst outcome when the M2BPGi and Fibroscan increase
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes in Complete Blood Count and Kidney function after secretome injections
Secretome is safe If hemoglobin and hematocrit, leukocyte, platelet, ureum, and creatinine are still in normal level after secretome injection (best outcome)
Secretome is not safe if hemoglobin and hematocrit, leukocyte, platelet, ureum, and creatinine are out of the normal level after secretome injection (worst outcome)
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of albumin, SGOT and SGPT levels in six month after secretome injections
Patients achieved a response if there are changes in albumin, SGOT and SGPT levels after secretome injections within six months.best outcome when the albumin, SGOT and SGPT decrease, worst outcome when the albumin, SGOT and SGPT increase
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Secondary outcomes (4)
Changes of CTP and MELD score in six month after secretome injections
Patients achieved a response if there are changes in CTP and MELD score after secretome injections within six months.best outcome when the CTP and MELD score decrease, worst outcome when the CTP and MELD score increase
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of IL-6 and TNF-α levels in six month after secretome injections
Patients achieved a response if there are changes in IL-6 and TNF-α levels after secretome injections within six months.best outcome when the IL-6 and TNF-α decrease, worst outcome when the IL-6 and TNF-α increase
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of Stroop test dan PHES score in six month after secretome injections
Patients achieved a response if there are changes inStroop test dan PHES score after secretome injections within six months.best outcome when the Stroop test dan PHES score increase, worst outcome when the Stroop test dan PHES score decrease
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of SF-36 questionnaire score in six month after secretome injections
Patients achieved a response if there are changes in SF-36 questionnaire score after secretome injections within six months.best outcome when the SF-36 questionnaire score increase, worst outcome when the SF-36 questionnaire score decrease
Measured: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baermed
- Sponsor type
- University, hospital or other
- Collaborators
- Tarumanagara University, Liver Clinic Prof Ali Sulaiman, Pelni Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629909
- Sponsor's protocol ID
- 017-UTHREC/UNTAR/VIII/2024
- Status last verified
- Sep 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Case Report Form (all collected IPD)
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Human Umbilical Cord Mesenchymal Stem Cell-Derived Secretome in the Treatment of Liver Cirrhosis: a Comprehensive Evaluation of Fibrosis Reduction, Immunomodulation, and Hepatic Regeneration a Single Center, Non-randomized, Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT06629909
- Acronym / sponsor ID
- 017-UTHREC/UNTAR/VIII/2024
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, secretome, stem cells, HUCMSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- BaermedUniversity, hospital or other
- Collaborators
- Tarumanagara University, Liver Clinic Prof Ali Sulaiman, Pelni Hospital
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Oct 2024 (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 goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with liver cirrhosis. The main questions it ams to answer are:
- How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients?
- How effective is secretome injection in liver fibrosis 6 months after injection?
- Does secretome injection improve liver function after 6 months after Injection?
- Does secretome injection affect Child Turcotte Pugh score?
- How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis?
- How does secretome injection affect the quality of life in live cirrhosis patient?
- What is the relationship between secretome injection and encephalopathy? Researchers will compare secretome injection group (patients who recieve secretome injections) to best practice treatment group (patient who receive supportive treatment including hepatoprotector and ursodeoxycolic acid)
Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored and given their usual drugs)
Patients will:
Be injected with secretome or take hepatoprotector and ursodeoxycolic acid every 2 weeks for 4 months. Do several test such us fibroscan, stroop test, psychometric hepatic encephalopathy score, short form 36 questionnaire, IL-6, TNF alfa and blood test for albumin, SGOT, SGPT, direct bilirubin, indirect bilirubin, INR, creatinine, ureum, hemoglobin, hematocrite, leukocyte, and thrombocyte.
Visit the clinic once every two weeks to receive drugs and treatment for 4 months.
Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment),10th months (6 months post treatment)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secretome Injection | Experimental | Drug: Secretomepatient will receive secretome injection every two weeks for four months |
| Best Treatment Practice | No intervention | –patient will receive hepatoprotector drugs and Urodeoxycolate acid for four months |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age above 17 years, both men and women
- Patient is willing to participate and sign informed consent
- Patient is diagnosed with liver cirrhosis confirmed by clinical examination and diagnostic imaging
- Liver cirrhosis patient with Child-Pugh Class B
- Patient is in a stable condition without life threatening complications such as active gastrointestinal bleeding, severe infection, severe renal failure (eGFR\&>30) at time of registration
Key exclusion criteria (4 listed)
- Patient with uncontrolled psychiatric disorders
- Patient who is diagnosed with hepatic or non- hepatic malignancy
- Lactating and pregnant patient
- Patient who has allergy or hypersensitivity reaction towards secretome
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 |
|---|---|---|
| SecretomeAlso: hepatoprotector drugs, ursodeoxycholic acid3 ml Injection of secretome for 8 times two weeks apart | Drug | Secretome Injection |
Primary outcome
Changes in Fibroscan and M2BPGi six month after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Patients achieved a response if there are changes in Fibroscan and M2BPGi after secretome injections within six months.best outcome when the M2BPGi Fibroscan decrease, worst outcome when the M2BPGi and Fibroscan increase
Changes in Complete Blood Count and Kidney function after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Secretome is safe If hemoglobin and hematocrit, leukocyte, platelet, ureum, and creatinine are still in normal level after secretome injection (best outcome) Secretome is not safe if hemoglobin and hematocrit, leukocyte, platelet, ureum, and creatinine are out of the normal level after secretome injection (worst outcome)
Changes of albumin, SGOT and SGPT levels in six month after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Patients achieved a response if there are changes in albumin, SGOT and SGPT levels after secretome injections within six months.best outcome when the albumin, SGOT and SGPT decrease, worst outcome when the albumin, SGOT and SGPT increase
4 secondary outcomes
Changes of CTP and MELD score in six month after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of IL-6 and TNF-α levels in six month after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of Stroop test dan PHES score in six month after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Changes of SF-36 questionnaire score in six month after secretome injections
Time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Case Report Form (all collected IPD)
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Secretome in people with Liver Cirrhosis, run by Baermed 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Ulrich Baer, Prof. Dr. med (628156963254, hans.baer@baermed.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fibroscan and M2BPGi six month after secretome injections (time frame: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months). The study lists 3 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 8 Oct 2024.