Biostage’s lab-grown replacement esophagus candidate has been placed on a clinical hold by the FDA as the company works to field questions from the agency before beginning initial human testing.
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 esophagus in people undergoing surgical removal of the organ due to cancer or pediatric disorders, for example.
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 tubelike scaffold and allowed to grow within a bioreactor.
After being implanted, the company expects the cells to signal and trigger the body’s own healing responses, leading to in situ regeneration of the full esophagus. Biostage is also exploring the potential of this approach in the bronchus and the trachea.
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After the company submitted its investigational new drug (IND) application for the esophageal implant in late October, Biostage said it received a series of questions from the FDA and provided what it described as preliminary responses, with more complete answers to follow.
On Nov. 27, the FDA placed the company’s Cellspan implant on clinical hold, while noting that additional time will be needed to fully answer its questions, the company said. To date, the implant has only been tested in a number of animal studies.
The FDA told Biostage that it will provide more details on the IND application's hold status by the end of the month, while the company works to finalize its responses.