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Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol
- Source :
- BMJ Open, Vol 13, Iss 12 (2023)
- Publication Year :
- 2023
- Publisher :
- BMJ Publishing Group, 2023.
-
Abstract
- Introduction There are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.Methods and analysis This study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0×107, 1.0×108, 1.5×108 or 2.0×108 cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.Ethics and dissemination The study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.Trial registration number NCT05227846.
- Subjects :
- Medicine
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 13
- Issue :
- 12
- Database :
- Directory of Open Access Journals
- Journal :
- BMJ Open
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.8efcea7844394c29a0f179c22bf606c0
- Document Type :
- article
- Full Text :
- https://doi.org/10.1136/bmjopen-2023-078362