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# Biostage Granted Orphan Status for Esophagus Cell Regenerator
- URL: https://www.fdaweb.com/biostage-granted-orphan-status-for-esophagus-cell-regenerator/
- Published: 2016-12-02T12:00:00.000Z
- Updated: 2026-09-14T21:52:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137480

FDA has granted Biostage an orphan drug designation for [Cellspan Esophageal Implant](http://www.biostage.com/cellspan-esophageal-implants?ref=fdaweb.com) to restore the structure and function of the esophagus after esophageal damage from cancer, injury or congenital abnormalities. “Based on preclinical, large-animal studies conducted to date, we believe our Cellspan esophageal implants may have the potential to offer improved outcomes for patients by reducing post-operative complications and providing an improved quality of life, by prompting regeneration of the patient's own esophagus,” the company says.

Biostage recently provided [a regulatory update](http://ir.biostage.com/2016-10-06-Biostage-Provides-Regulatory-Update-of-Cellspan-Esophageal-Implant?ref=fdaweb.com) on Cellspan following a “substantive” pre-IND meeting with FDA. The feedback provided by the agency “provided clarity for a clinical path forward” to advance into Phase 1 human clinical studies, the company says. The studies are expected to begin in the fourth quarter next year.

The company’s proprietary Cellframe technology uses a multi-step process in which the patient’s own stem cells are taken from a simple adipose/fat tissue biopsy, expanded and banked, and then seeded onto a proprietary scaffold that mimics the natural dimensions of the organ being regenerated. After several days in a rotating bioreactor, the biocompatible scaffold containing the stem cells is ready to be implanted, according to Biostage.