The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine AB-1002 for the treatment of congestive heart failure. The public consultation will take place from 16 July to 15 August 2025.
For each clinical trial application for the use of a genetically modified organism, the government organises a 30-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can give your opinion on this clinical trial application with a genetically modified medicine.
Congestive heart failure (CHF) is a serious condition where the heart is no longer able to pump sufficient blood through the body. This leads to a buildup of fluid in body tissues causing shortness of breath, tiredness, and swelling in the abdomen and legs. In case of severe heart failure, there are only limited treatment options, and sometimes heart transplants or other surgical procedures may be required. This shows the need for new treatment strategies for patients with CHF.
In this clinical trial, the investigational medicine AB-1002 will be administered via a single infusion directly into the main arteries supplying blood to the heart of the patient. AB-1002 is used as gene therapy where a functional gene is introduced here to improve the way calcium is used within the heart muscle cells. This allows the heart to pump blood more effectively through the body and deliver enough blood to the organs.
The aim of this trial is to assess the safety and efficacity of AB-1002 in adult CHF patients.
The clinical trial will take place at AZORG in Aalst, the University Hospital in Antwerp (Edegem), the University Hospital in Ghent and Algemeen Ziekenhuis Delta in Roeselare.
How to give your opinion?
The public consultation runs from 16 July to 15 August 2025 inclusive. You can access the various data in the application file, as well as an online form to send your comments or ask your questions.