Clinical trial
A Phase I, Open-label Trial on the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cell Administration in the Management of Adult Liver Cirrhosis
Name
ISC.19.29
Description
This is a phase I, open label, single arm trial using UC-MSCs to treat patients with liver cirrhosis that includes 20 patients. The primary outcome measure will be change in MELD score at 3, 6, and 12 months after UC-MSC transplantation from baseline. The safety is assessed by frequency and severity of the adverse event or serious adverse event associated with stem cell injection. This study could reconfirm the efficacy of stem cell transplantation for liver cirrhosis and would open a novel cell therapy for the treatment of adult liver cirrhosis.
Trial arms
Trial start
2020-11-01
Estimated PCD
2022-08-30
Trial end
2023-09-30
Status
Completed
Phase
Early phase I
Treatment
Human umbilical cord-derived mesenchymal stem cell infusion
Human umbilical cord-derived mesenchymal stem cell infusion in the management of adult liver cirrhosis
Arms:
human umbilical cord-derived mesenchymal stem cell transplantation for patients with liver cirrhosis
Size
20
Primary endpoint
Number of Adverse events and serious adverse events (AEs or SAEs)
up to the 12-month period following the first UC-MSCs infusion
Eligibility criteria
Inclusion Criteria:
* Aged 18 to 70 years old.
* Patients diagnosed of liver cirrhosis: splenomegaly, elevated hepatic enzymes and/or esophageal varices detected by endoscopy, or liver biopsy demonstrated liver cirrhosis
* Be willing to complete the study and sign the consent form.
Exclusion Criteria:
* Younger than 18 or older than 70 years old
* Recent infection
* Patients with history of chronic diseases such as cancer, chronic hepatitis, chronic kidney disease.
* Any clinically significant blood coagulation disorder(s)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-06-04
1 organization
1 product
1 indication
Indication
Cirrhosis