Clinical Research of Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 18 years old ≤ age ≤ 70 years old, gender is not limited.

• Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg/dl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.

• Willing to sign the informed consent form.

Locations
Other Locations
China
the Fifth Medical Center, Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Tao Yang, MD
y_t_0321@163.com
86-010-66933333
Backup
Yanhu Wang, MM
2440477984@qq.com
86-010-66933328
Time Frame
Start Date: 2023-09-30
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 150
Treatments
Placebo_comparator: Group Control
standard medical treatment+Placebo(5% human serum albumin in 0.9% saline, at week0, week1 and week2)
Experimental: Group MSC-1
Patients received standard medical treatment and infusions of hUC-MSC(1.5×10\^8) via peripheral veins once a week for 3 timess(at week0, week1, and week2).
Experimental: Group MSC-2
Patients in Group MSC-1 received standard medical treatment and infusions of hUC-MSC(1.5×10\^8) via peripheral veins once a week for another 2 timess(at week4 and week5).
Related Therapeutic Areas
Liver Failure
Bone Marrow Transplant
Sponsors
Collaborators: Shulan (Hang Zhou) Hospital, BeijingYouan Hospital, Shen Zhen Wingor Biotechnology CO. LTD, Shenzhen Third People's Hospital
Leads: Beijing 302 Hospital

This content was sourced from clinicaltrials.gov

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