NCT06629909

Brief 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. 1.How safe is secretome Injection as an adjuvant therapy for liver cirrhosis patients?
  2. 2.How effective is secretome injection in liver fibrosis 6 months after injection?
  3. 3.Does secretome injection improve liver function after 6 months after Injection?
  4. 4.Does secretome injection affect Child Turcotte Pugh score?
  5. 5.How does secretome affect pro inflammatory and anti Inflammatory cytokine in patient with liver cirrhosis?
  6. 6.How does secretome injection affect the quality of life in live cirrhosis patient?
  7. 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)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
6mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2024Oct 2026

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

October 4, 2024

Last Update Submit

October 4, 2024

Conditions

Liver Cirrhosis

Keywords

liver cirrhosissecretomestem cellsHUCMSC

Outcome Measures

Primary Outcomes (3)

  • Changes in Fibroscan and M2BPGi six month after secretome injections

    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

    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

    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 Outcomes (4)

  • Changes of CTP and MELD score in six month after secretome injections

    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

    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

    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

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

Study Arms (2)

Secretome Injection

EXPERIMENTAL

patient will receive secretome injection every two weeks for four months

Drug: Secretome

Best Treatment Practice

NO INTERVENTION

patient will receive hepatoprotector drugs and Urodeoxycolate acid for four months

Interventions

SecretomeDRUG

3 ml Injection of secretome for 8 times two weeks apart

Also known as: hepatoprotector drugs, ursodeoxycholic acid
Secretome Injection

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Clinic Prof Ali Sulaiman

Jakarta, DKI Jakarta, 10150, Indonesia

Location

Related Links

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

SecretomeUrsodeoxycholic Acid

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MetabolomeMetabolismDeoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Central Study Contacts

Hans Ulrich Baer, Prof. Dr. med

CONTACT

628156963254hans.baer@baermed.ch

Siufui Hendrawan, M.D., Ph.D.

CONTACT

+41 387 30 70siufui@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

December 1, 2024

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Last Updated

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Case Report Form (all collected IPD)

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After publication with no end date

Locations

ID(1)