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

Baermed

Status and phase: Not yet enrolling; Phase 1

Conditions: Liver Cirrhosis

Treatments: Drug: Secretome

Study type: Interventional

Funder types: Other

Identifiers

NCT06629909

017-UTHREC/UNTAR/VIII/2024

Details and patient eligibility

About

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)

Enrollment: 54 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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&amp>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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Secretome Injection

Experimental group

Description:

patient will receive secretome injection every two weeks for four months

Treatment:

Drug: Secretome

Best Treatment Practice

No Intervention group

Description:

patient will receive hepatoprotector drugs and Urodeoxycolate acid for four months