NCT06629909

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Baermed · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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. 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)

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Secretome	3 ml Injection of secretome for 8 times two weeks apart

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-10-31
• Completion: 2026-10-31
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: Indonesia