Company regenerates esophagus in preclinical work with Mayo Clinic.
The study demonstrated in a predictive large-animal model the ability of Biostage Cellspan organ implants to successfully stimulate the regeneration of sections of esophagus that had been surgically removed for the study.
Cellspan esophageal implants, consisting of a proprietary biocompatible synthetic scaffold seeded with the recipient animal's own stem cells, were surgically implanted in place of the esophagus section that had been removed.
Study animals were returned to a solid diet two weeks after implantation surgery.
The scaffolds, which are intended to be in place only temporarily, were later retrieved via the animal's mouth in a non-surgical endoscopic procedure.
After 2.5 months, a complete epithelium and other specialized esophagus tissue layers were fully regenerated.
Animals gained weight gain and appeared healthy and free of any significant side effects.
A few are now more than 90 days post implantation, and are receiving no specialized care.
There was no evidence of leakage or infection at the surgery sites in any of the animals studied.
Such issues pose regular and life-threatening dangers for esophageal cancer patients surgically treated with the existing standards of care.
Developed over the past two years, Cellframe technology uses a new approach to creating organ implants, including new materials, new protocols and a different mechanism of action.
Prior organ implant technologies sought to incorporate the scaffold into the body wherein the surrounding native tissue would grow into, or incorporate, the scaffold.
However this approach was challenged by the body's immune response, creating significant complications.
In the Cellframe approach, the scaffold serves as a temporary host structure that delivers the necessary cells in a suitable form and manner to support regeneration.
Cellspan implants use a biocompatible tubular structure or scaffold to guide the formation of new tissue.
Prior to implantation, stem cells from each subject are "seeded" on the scaffold to stimulate tissue regeneration as well as to help reduce any potential inflammatory or rejection response.
Once initial regeneration activity has taken place, the scaffold is retrieved, enabling the inner surface to continue the regeneration process from both ends.
CEO Jim McGorry said data suggest the Cell-span esophageal implant could be a break-through alternative to the current surgical procedures used to address esophageal cancer.
The company believes it has sufficient data to initiate Good Laboratory Practice (GLP) studies to demonstrate that its technology, personnel, systems and practices are sufficient for advancing into clinical trials.
GLP studies are required to advance to an Investigational New Drug (IND) application with the FDA which would seek approval to initiate clinical trials for Biostage Cellspan esophageal implants in humans.
Biostage expects to complete its IND filing by year-end 2016
In related news, the company on May 16 announced that institutional investors have agreed to buy shares of common stock with gross proceeds of approximately $5 million in an at-the-market registered direct offering.
The closing of the offering was expected to take place on or about May 19.
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|Title Annotation:||Preclinical Research|
|Publication:||Stem Cell Business News|
|Date:||May 16, 2016|
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