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NCT Number: 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

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)

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Liver Clinic Prof Ali Sulaiman

Jakarta, DKI Jakarta, 10150, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Secretome

Drug

3 ml Injection of secretome for 8 times two weeks apart

Other names: hepatoprotector drugs, ursodeoxycholic acid

Primary outcomes

  1. 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

  2. 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)

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hans Ulrich Baer, Prof. Dr. med

CONTACT

[email protected]

628156963254

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

CONTACT

[email protected]

+41 387 30 70

Sponsors and collaborators

Lead sponsor

Baermed

Other

Collaborators

  • Liver Clinic Prof Ali Sulaiman
  • Pelni Hospital
  • Tarumanagara University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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