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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secretome.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: from 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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. How effective is secretome injection in liver fibrosis 6 months after injection? 3. Does secretome injection improve liver function after 6 months after Injection? 4. Does secretome injection affect Child Turcotte Pugh score? 5. How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis? 6. How does secretome injection affect the quality of life in live cirrhosis patient? 7. 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)
Interventions
- Drug Secretome
3 ml Injection of secretome for 8 times two weeks apart
Primary outcome measures
- 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]
- 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]
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- Liver Clinic Prof Ali Sulaiman — Jakarta
Identifiers
NCT: NCT06629909 · 017-UTHREC/UNTAR/VIII/2024