Biostage, Inc., a cell-therapy biotechnology company with successful first-in-human experience repairing the esophagus after the cancer in the patient’s esophagus had been surgically removed* and FDA approval to commence a clinical trial of the Biostage Esophageal Implant for severe esophageal disease including cancer, today announced the publication of a paper in the peer-reviewed Journal of Immunology and Regenerative Medicine that describes the early tissue growth and regeneration processes following the implantation of the Biostage Esophageal Implant (BEI) in nine pigs with full circumferential esophageal segmental replacement. The BEI stimulated new blood vessel growth and all animals regenerated a continuous biological conduit by 28 days. In some animals the continuous biological conduit was seen as early as 14 days. The paper can be accessed through the following link: https://doi.org/10.1016/j.regen.2022.100068. The regeneration time period as noted in the paper compares favorably with the primary endpoint of Biostage’s FDA-approved clinical trial which is to show a continuous biological conduit by 90 days. Biostage expects to initiate patient recruitment in its first clinical trial in early 2023.
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The Biostage Esophageal Implant (previously known as Cellspan Esophageal Implant) stimulates the regeneration of new tissue to repair the esophagus following a full circumferential segmental resection. The paper in the Journal of Immunology and Regenerative Medicine describes a study that investigated the early growth and tissue composition of the newly developed tissue as well as the fate of the adipose derived mesenchymal stromal cells (Ad-MSC) that are seeded onto the scaffold prior to implantation. The BEI bridged the esophageal ends and restored the conduit by stimulating a regeneration process that includes rapid neovascularization followed by mucosal regeneration that was quantified from day 14 to day 28 post-implantation.
David Green, Interim Chief Executive Officer of Biostage, commented: “We are pleased to announce the publication of this study which describes the early phases of the rapid tissue regeneration stimulated by the Biostage Esophageal Implant and demonstrates that by as early as day 14 post-implantation a complete biologic esophageal conduit is restored.
Dr William Fodor, Chief Scientific Officer of Biostage, added: “This study demonstrates that rapid tissue deposition and the stimulation of angiogenesis (new blood vessel growth) leads to a productive healing and regeneration response. We also quantified the rate of early epithelialization on the lumenal (interior) surface as well as determined the fate of the Ad-MSC component of the graft.”
SOURCE: PR Newswire