Following an FDA-approved single-use expanded access application, Biostage Inc. has announced that surgeons used its Cellspan esophageal implant product candidate on a patient to reconstruct the esophagus during surgery at a major U.S. hospital, according to a press release. Biostage believes that these results indicate the Cellspan esophageal implant has performed as designed, per the release.
The surgeons implanted the product into a man aged 75 years who had a life-threatening tumor in the chest that had encroached on other vital organs. During the surgery, they removed a portion of the esophagus affected by the cancer and used the esophageal implant to reconstruct the organ. The patient is still alive, three months after the surgery.
Biostage worked in collaboration with the University of Texas Health Science Center at Houston. Researchers processed, seeded and grew the patient’s stem cells onto the scaffold before releasing them for transport to the institution conducting the surgery, per the press release.
“The Cellspan esophageal implant has the potential to significantly improve quality of life for a patient who has undergone an esophageal resection, as it improves upon the current standard of care for the treatment of esophageal cancer,” Jim McGorry, CEO of Biostage, said. “Regeneration of the esophagus in a high-risk patient and under extremely trying conditions, such as evidenced to date in this case, indicates that the regenerative properties of the implant may be reproducible in other patients.”
Disclosures: McGorry is CEO of Biostage.