Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure

Kebo Zhong

Status and phase: Enrolling; Phase 1

Conditions: Liver Failure

Treatments: Device: It is loaded with a mesenchymal stem cells reaction device for blood purification

Study type: Interventional

Funder types: Other

Identifiers

NCT06904755

Zhujiang Hospital

Details and patient eligibility

About

The goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. The main questions it aims to answer are:1.Does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.What medical problems do participants have when taking mesenchymal stem cells in blood purification? Participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.These cells work outside the body and do not enter the body. We will: 1.Collect samples from participants such as blood, Urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, Inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Blood purification with mesenchymal stem cells therapy group

Experimental group

Treatment:

Device: It is loaded with a mesenchymal stem cells reaction device for blood purification