Transplanting stem cells from umbilical cords to treat severe liver cirrhosis
A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
This study is testing if infusing stem cells from umbilical cords can help people with severe liver cirrhosis who haven't improved with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Asia Stem Cell Regenerative Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Haikou) |
| Trial ID | NCT05106972 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of umbilical cord mesenchymal stem cell (UC-MSC) transplantation in patients suffering from decompensated hepatitis B cirrhosis. Participants will receive an infusion of UC-MSCs to assess improvements in their liver condition and overall health. The study focuses on individuals who have not responded to conventional treatments and are not candidates for liver transplantation. The goal is to determine if this innovative approach can provide a viable alternative for managing this severe liver disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 60 with chronic decompensated hepatitis B cirrhosis lasting more than 5 years and who are not suitable for liver transplantation.
Not a fit: Patients with cirrhosis caused by factors other than hepatitis B or those with active liver tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new hope for patients with severe liver cirrhosis who have limited options.
How similar studies have performed: While the use of stem cells for liver conditions is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 20 and 60 (male or female) * Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years * Not suitable for liver transplantation or there is no donor liver source * No serious bleeding tendency or active bleeding * No hepatic encephalopathy * After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score * Subjects voluntarily participate in this study and sign informed consent Exclusion Criteria: * Be less than 20 years old or more than 60 years old * Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis * Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives * Patients with hypersplenism who need splenectomy * History of tumors in other organs * PT prolongation is greater than 3 seconds * Use of human serum albumin within 3 weeks prior to clinical registration * Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration * Spontaneous peritonitis * Active infection (viral or bacterial) * Pregnant or lactating women * The researcher considers it inappropriate to participate in this study
Where this trial is running
Haikou
- Haikou People's Hospital — Haikou, China (Recruiting)
Study contacts
- Study coordinator: Xiaoxi Huang, PHD
- Email: huangxiaoxi@xibaozhiliao.cn
- Phone: 86-0898-66151200
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.