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

October 4, 2024 updated by: Baermed

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:

  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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Siufui Hendrawan, M.D., Ph.D.
  • Phone Number: +41 387 30 70
  • Email: siufui@gmail.com

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10150
        • Liver Clinic Prof Ali Sulaiman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Secretome Injection
patient will receive secretome injection every two weeks for four months
Drug: Secretome
3 ml Injection of secretome for 8 times two weeks apart
Other Names:
  • ursodeoxycholic acid
  • hepatoprotector drugs
No Intervention: Best Treatment Practice
patient will receive hepatoprotector drugs and Urodeoxycolate acid for four months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

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)
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
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
From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baermed

Collaborators

Tarumanagara University
Liver Clinic Prof Ali Sulaiman
Pelni Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017-UTHREC/UNTAR/VIII/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Case Report Form (all collected IPD)

IPD Sharing Time Frame

After publication with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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