MedTrace Logo

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

NCT06629909 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-10-08

No results posted yet for this study

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

Interventions

DRUG

Secretome

3 ml Injection of secretome for 8 times two weeks apart

Sponsors & Collaborators

  • Tarumanagara University

    collaborator OTHER

  • Liver Clinic Prof Ali Sulaiman

    collaborator UNKNOWN

  • Pelni Hospital

    collaborator UNKNOWN

  • Baermed

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629909 on ClinicalTrials.gov