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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат Secretome
  3 ml Injection of secretome for 8 times two weeks apart

Первичные конечные точки

• Changes in Fibroscan and M2BPGi six month after secretome injections [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months]

Вторичные конечные точки (4)

• Changes of CTP and MELD score in six month after secretome injections [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 4 months, From enrollment to the end of study at 10 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Liver Clinic Prof Ali Sulaiman — Jakarta

Идентификаторы

NCT: NCT06629909 · 017-UTHREC/UNTAR/VIII/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗