Esophageal Implant for Esophageal Reconstruction

This trial tests a new esophageal implant called the Cellspan™ Esophageal Implant (CEI), which combines a synthetic scaffold with a person's own stem cells to help regrow a damaged esophagus. It is designed for individuals needing a section of their esophagus rebuilt, particularly those with stubborn esophageal narrowing or holes that have not improved after other treatments. Ideal candidates for this trial are those who have had at least three different treatments fail and require surgery to repair a short part of their esophagus. The trial aims to determine if this implant can safely and effectively aid in healing the esophagus and restoring its function. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that the Cellspan™ Esophageal Implant (CEI) is still undergoing safety testing in humans. Earlier studies found that similar esophageal grafts can be successfully used for esophageal reconstruction in people. However, since this is the first human trial for the CEI, information on patient tolerance and potential side effects remains limited.

Most treatments for esophageal reconstruction involve complex surgeries or grafts using tissue from other parts of the body, which can be invasive and come with significant recovery time. The Cellspan™ Esophageal Implant (CEI) is unique because it offers a potentially less invasive alternative that uses a synthetic scaffold to encourage the body's own cells to regenerate the esophagus. This innovative approach not only reduces the need for extensive surgery but also aims to improve healing by harnessing the body's natural regenerative processes. Researchers are excited about this treatment because it could lead to quicker recovery times and fewer complications, revolutionizing how we approach esophageal reconstruction.

Research has shown that the Cellspan™ Esophageal Implant (CEI), which participants in this trial will receive, has yielded promising results in animal studies. In pigs, the implant facilitated tissue regrowth after esophagus removal, forming a new, continuous tube-like structure. Early findings also suggest that mesenchymal stem cells can repair the esophagus rapidly, in about two weeks. Although data on humans is limited, these results provide a strong basis for expecting similar outcomes in people.¹²³⁵⁶