Using mesenchymal stem cells for blood purification to treat liver failure
Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
PHASE1 · Zhujiang Hospital · NCT06904755
This study is testing if using stem cells to clean the blood can help adults with liver failure feel better and improve their health.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06904755 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of mesenchymal stem cells used in blood purification for treating liver failure in adults. Participants will receive standard medical treatment alongside blood purification that utilizes these stem cells, which operate outside the body. The study will collect various biological samples and monitor outcomes such as survival rates and liver disease indicators over several weeks. The primary focus is to determine if this innovative approach can improve patient conditions and identify any associated medical issues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with acute liver failure in early to intermediate stages.
Not a fit: Patients with severe active bleeding, circulatory failure, or significant allergies to blood products may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from liver failure.
How similar studies have performed: While the use of mesenchymal stem cells in various treatments has shown promise, this specific application in blood purification for liver failure is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang hospital — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Kebo Zhong, doctor
- Email: zhongkb@smu.edu.cn
- Phone: 8615360629197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Failure