FDA places Biostage’s oesophagus implant on holdFebruary 5, 2020
Biostage’s lab-grown replacement oesophagus candidate the Cellspan Esophageal Implant (CEI) has been placed on a clinical hold by the USFDA, the company announced.
Biostage received questions from the FDA following its IND application in late October. The company provided preliminary responses to these questions and notified the agency that a complete response would follow. Biostage is working to finalise responses to the FDA questions.
The company aims to use a biocompatible scaffold seeded with a patient’s own cells to build an individualized, regenerative implant. This could replace the practice of using parts of the stomach or intestine to create a mock oesophagus in people undergoing surgical removal of the organ due to cancer or paediatric disorders, for example.
Biostage is developing its Cellspan oesophageal implant for the treatment of oesophageal atresia in a process that takes three to four weeks, stem cells are derived from a biopsy of the patient’s fat tissue, cultured and then placed on a tube-like scaffold and allowed to grow within a bioreactor.
Esophageal atresia is a birth disorder of the digestive system in which the oesophagus does not develop properly. In most cases, the upper oesophagus does not connect with the lower oesophagus and stomach. Esophageal atresia occurs in about 1 in every 4,000 live births worldwide.