In short
This article provides information about ongoing clinical trials for acute hepatic failure and related liver conditions. Currently, there is 1 clinical trial investigating long-term safety of cell-based therapy for patients with specific liver disorders including urea cycle disorders, Crigler-Najjar syndrome, and fibroinflammatory liver diseases. The trial is being conducted across multiple European countries.
Clinical trial locations
- Belgium
- Bulgaria
- France
- Poland
- Spain
Long-Term Safety Study of HepaStem for Patients with Urea Cycle Disorders, Crigler-Najjar Syndrome, and Fibroinflammatory Liver Diseases
This trial focuses on monitoring the long-term safety of a cell therapy treatment called HepaStem in patients with specific liver-related conditions. The study is designed for patients who have already received at least one infusion of HepaStem in earlier clinical trials and aims to track their health over an extended period, continuing until July 2028.
Main inclusion criteria: To participate in this study, patients must have received at least one infusion of HepaStem during a previous clinical study. Participants need to be able to understand and provide written informed consent. For children, consent must be given by parents or legal representatives, and if the child is old enough to understand, they should also agree to participate. If a minor participant becomes an adult during the study, they must provide their own consent. The study is open to both male and female patients and includes individuals from vulnerable populations who may require special care or protection.
Main exclusion criteria: Patients who have not received at least one infusion of HepaStem in a previous study cannot participate. Those who did not take part in earlier clinical studies conducted by Promethera Biosciences or Promethera Therapeutics are not eligible. Additionally, patients who do not have urea cycle disorders, Crigler-Najjar syndrome, or fibroinflammatory liver diseases cannot join the study.
Focus and goal of the trial: The primary purpose of this trial is to assess the long-term safety of HepaStem therapy. Researchers will monitor participants for any health issues or adverse events that may occur after receiving the treatment. This includes documenting significant health events such as organ transplantation, development of tumors, or diseases linked to infections or reactivation of dormant viruses. Participants will not receive any new treatments during this study but will undergo regular follow-ups to gather comprehensive information about their health status following their initial HepaStem treatment. This monitoring helps researchers understand whether the therapy remains safe over time.
Investigational drug: HepaStem is a cell therapy that uses special cells derived from the liver. These cells are designed to help repair and regenerate damaged liver tissue. The therapy aims to support liver function and improve the health of patients with liver conditions by providing the liver with necessary cells to aid in its healing process. In this trial, the focus is specifically on understanding how safe HepaStem is over a long period after patients have received it.
Summary
Currently, there is one ongoing clinical trial available for patients with liver-related conditions including urea cycle disorders, Crigler-Najjar syndrome, and fibroinflammatory liver diseases. This trial is notable for its broad geographic reach across five European countries: Belgium, Bulgaria, France, Poland, and Spain. The study focuses exclusively on the long-term safety monitoring of HepaStem, a liver-derived cell therapy, rather than testing new treatments. This approach provides valuable information about the lasting effects of cell-based therapies for liver conditions. The trial is particularly accessible to patients who have previously participated in HepaStem studies and represents an important step in understanding the safety profile of innovative cell therapies for serious liver disorders.
