Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
Launched by KEBO ZHONG · Mar 29, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for adults with liver failure using a special kind of cell called mesenchymal stem cells, which help with blood purification. The main goal is to see if this treatment can improve the health of patients with liver failure and to understand if there are any side effects. Participants will continue to receive their regular medical care, and blood purification with these stem cells will be done outside the body. Researchers will collect samples like blood and urine and track patients' health over time to see how well the treatment works.
To be eligible for this trial, participants must be between 18 and 65 years old and have acute liver failure that is in the early to middle stages. They should also meet certain health criteria, such as specific levels of bilirubin and prothrombin activity, which are indicators of liver function. Not everyone will qualify; those with severe bleeding, certain allergies, serious heart or lung issues, or other health problems may not be included. Participants can expect regular check-ins and monitoring as part of the study. This trial is an important step in finding new ways to help people with liver failure recover and improve their quality of life.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age range from 18 to 65 years old;
- • 2. Patients with acute liver failure in the early and intermediate stages caused by various reasons;
- • 3. Total bilirubin (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
- • 4. Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6);
- • 5. No hepatic encephalopathy or encephalopathy below grade II (including grade II);
- • 6. Elevated inflammatory markers (IL-6 / TNF-α / CRP, etc.);
- • 7. The subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations;
- • 8. The subjects must be informed of this study and voluntarily sign a written informed consent form before the experiment.
- Exclusion Criteria:
- • 1. Patients with severe active bleeding or diffuse intravascular coagulation;
- • 2. Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;
- • 3. Patients with circulatory failure;
- • 4. Patients with a MELD score \> 30;
- • 5. Patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes;
- • 6. Subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.
About Kebo Zhong
Kebo Zhong is a distinguished clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing novel therapeutics and enhancing patient care, Kebo Zhong collaborates with leading research institutions and healthcare professionals to conduct rigorous clinical trials. The organization prioritizes ethical standards and regulatory compliance, ensuring the safety and efficacy of its investigational products. Through its dedication to scientific excellence and patient-centric approaches, Kebo Zhong aims to contribute significantly to the healthcare landscape and improve outcomes for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported